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125742 0_20219001.P0.pdfNovember 1, 2023912 KB
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125742_S116_M1_lab 1448 1 0.pdfNovember 1, 20231 MB
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125742_S112_S2_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
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125742_S112_M1_cover.pdfNovember 1, 20232 MB
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125742_S111_M1_letter of authorization.pdfNovember 1, 2023739 KB
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125742_S111_M1_356h.pdfNovember 1, 20234 MB
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125742_S80_M1_cover.pdfNovember 1, 2023734 KB
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125742_S63_M1_response 18aug2021.pdfNovember 1, 20232 MB
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125742_S61_M1_response 17aug2021.pdfNovember 1, 20232 MB
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125742_S61_M1_cover.pdfNovember 1, 2023668 KB
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125742_S60_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
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125742_S60_M1_response 17aug2021.pdfNovember 1, 20232 MB
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125742_S60_M1_cover.pdfNovember 1, 20232 MB
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125742_S59_M1_response 17aug2021.pdfNovember 1, 20231 MB
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125742_S59_M1_cover.pdfNovember 1, 2023672 KB
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125742_S57_M3_32p3_manufacturer diluent.pdfNovember 1, 20232 MB
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125742_S57_M1_response 16aug2021.pdfNovember 1, 20232 MB
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STN 124742_Courtesy Copy_Pfizer BioNTech Comirnaty STN 125742 COVID 19 Vaccine Lot Notifications (2021).pdfNovember 1, 2023200 KB
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FDA CBER 2021 5683 1150835 1200874_Slipsheet.pdfNovember 1, 202369 KB
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125742 0_20219009.P0.pdfNovember 1, 2023889 KB
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125742 0_20219002.P0.pdfNovember 1, 2023905 KB
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125742 0_20219001.PC1.pdfNovember 1, 2023912 KB
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125742_S56_M1_response 13aug2021.pdfNovember 1, 20232 MB
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125742_S56_M1_cover.pdfNovember 1, 2023672 KB
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125742_S55_M3_32p8_stability summary.pdfNovember 1, 20233 MB
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125742_S55_M3_32p8_stability data long term.pdfNovember 1, 20233 MB
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125742_S55_M2_introduction.pdfNovember 1, 202311 MB
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125742_S55_M2_drug product stability.pdfNovember 1, 20233 MB
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125742_S55_M2_32p8_stability data accelerated.pdfNovember 1, 20233 MB
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125742_S55_M1_cover.pdfNovember 1, 2023767 KB
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125742_S53_M1_response 13aug2021.pdfNovember 1, 20231 MB
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125742_S53_M1_cover.pdfNovember 1, 2023675 KB
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125742_S50_M3_32r_comirnaty lot release template.pdfNovember 1, 20232 MB
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125742_S50_M1_response 13aug2021.pdfNovember 1, 20232 MB
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125742_S50_M1_cover.pdfNovember 1, 20232 MB
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125742_S48_M1_response 06aug2021.pdfNovember 1, 20232 MB
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125742_S47_M3_32p3_manufacturer diluent.pdfNovember 1, 20232 MB
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125742_S47_M1_response 11aug2021.pdfNovember 1, 20232 MB
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125742_S44_M1_response 10aug2021.pdfNovember 1, 20232 MB
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125742_S43_M3_32p3_manufacturers.pdfNovember 1, 20232 MB
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125742_S43_M1_response 05aug2021.pdfNovember 1, 20232 MB
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125742_S42_M3_32r_comirnaty lot release template.pdfNovember 1, 2023709 KB
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125742_S42_M1_response 04aug2021.pdfNovember 1, 20234 MB
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125742_S40_M1_response 06aug2021.pdfNovember 1, 20232 MB
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125742_S37_M1_response 05aug2021.pdfNovember 1, 20232 MB
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125742_S36_M1_response 02aug2021.pdfNovember 1, 20232 MB
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125742_S34_M3_32a3_excipient information nomenclature alc 0315.pdfNovember 1, 20232 MB
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125742_S57_M1_cover.pdfNovember 1, 20232 MB
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125742_S30_M1_cover.pdfNovember 1, 2023671 KB
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125742_S26_M1_fda bnt cl.pdfNovember 1, 2023996 KB
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125742_S26_M1_andover 483 response.pdfNovember 1, 20231 MB
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125742_S25_M1_response 26jul2021.pdfNovember 1, 20231 MB
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125742_S22_M1_response 16jul2021.pdfNovember 1, 20231 MB
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125742_S19_M1_response 02jul2021.pdfNovember 1, 20232 MB
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125742_S17_M1_reponse 09jul2021.pdfNovember 1, 20232 MB
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125742_S17_M1_cover.pdfNovember 1, 2023674 KB
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125742_S15_M3_32r_comirnaty lot release 16jul2021.pdfNovember 1, 20231 MB
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125742_S15_M1_response 16jul2021 lrp samples.pdfNovember 1, 20231 MB
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125742_S15_M1_cover.pdfNovember 1, 2023675 KB
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125742_S11_M3_32r_pf 07302048 dp rm coa.pdfNovember 1, 2023634 KB
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125742_S11_M3_32r_fd0809 coa.pdfNovember 1, 2023836 KB
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125742_S11_M3_32r_fc3181 coa.pdfNovember 1, 2023840 KB
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125742_S11_M3_32r_677365 1g a 010 coa.pdfNovember 1, 2023636 KB
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125742_S11_M3_32r_677315o 1g a 010 coa.pdfNovember 1, 2023635 KB
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125742_S11_M3_32r_677159p 1g a 010 coa.pdfNovember 1, 2023636 KB
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125742_S11_M3_32r_21y513c2501 coa.pdfNovember 1, 2023636 KB
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125742_S11_M3_32r_21y513c2401 coa.pdfNovember 1, 20231 MB
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125742_S11_M3_32r_21y513c2301 coa.pdfNovember 1, 20231 MB
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125742_S11_M1_response 25jun2021 cmc.pdfNovember 1, 20232 MB
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125742_S11_M1_cover.pdfNovember 1, 20232 MB
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125742_S5_M1_response 20 may 2021 facilities.pdfNovember 1, 20231 MB
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125742_S5_M1_cover.pdfNovember 1, 2023725 KB
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125742_S2_M3_32s4_validation analyt procedure overview.pdfNovember 1, 20232 MB
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125742_S2_M3_32s4_specification.pdfNovember 1, 20232 MB
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125742_S2_M3_32s4_analytical procedure overview.pdfNovember 1, 20232 MB
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125742_S34_M1_cover.pdfNovember 1, 2023668 KB
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125742_S30_M1_response 26jul2021.pdfNovember 1, 20231 MB
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125742_S2_M3_32r_reg info manufacturing schedules.pdfNovember 1, 20232 MB
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125742_S2_M3_32r_reg info lot release documentation package.pdfNovember 1, 20234 MB
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125742_S2_M3_32p53_validation analytical procedures overview.pdfNovember 1, 20232 MB
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125742_S2_M3_32p53_validation analytical procedure rt pcr.pdfNovember 1, 20232 MB
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125742_S2_M3_32p53_validation analytical procedure cap gel electro.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure subvis particulate matter.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure rt pcr.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure overview.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure osmometry.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure endotoxin.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure cap gel electro.pdfNovember 1, 20232 MB
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125742_S2_M3_32p8_stability summary.pdfNovember 1, 20232 MB
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125742_S2_M3_32p8_stability data thermal stress cycling.pdfNovember 1, 20233 MB
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125742_S2_M3_32p8_stability data photostability.pdfNovember 1, 20232 MB
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125742_S2_M3_32p8_stability data long term.pdfNovember 1, 20232 MB
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125742_S2_M3_32p8_stability data accelerated.pdfNovember 1, 20232 MB
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125742_S2_M3_32p8_postapproval stability.pdfNovember 1, 20232 MB
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125742_S2_M3_32p5_specifications.pdfNovember 1, 20232 MB
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125742_S2_M3_32p5_batch analyses.pdfNovember 1, 20233 MB
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125742_S2_M3_32p4_novel excipients.pdfNovember 1, 20232 MB
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125742_S2_M3_32p4_excipients human animal.pdfNovember 1, 20232 MB
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125742_S2_M3_32p3_manufacturers.pdfNovember 1, 20232 MB
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125742_S2_M3_32p3_control critical steps in process mon control overview.pdfNovember 1, 20232 MB
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125742_S2_M3_32p3_batch formula.pdfNovember 1, 20232 MB
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125742_S2_M3_32p2_pharmaceutical development introduction.pdfNovember 1, 20232 MB
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125742_S2_M3_32p1_description and composition.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information structure alc 0315.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information structure alc 0159.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information nomenclature alc 0315.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information nomenclature alc 0159.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information excipients alc 0315.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information excipients alc 0159.pdfNovember 1, 20232 MB
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125742_S2_M3_32a2_adventitious agents puurs.pdfNovember 1, 20232 MB
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125742_S2_M3_32a2_adventitious agents kalamazoo.pdfNovember 1, 20232 MB
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125742_S2_M3_32a2_adventitious agents andover.pdfNovember 1, 20232 MB
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125742_S2_M2_introduction.pdfNovember 1, 20232 MB
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125742_S2_M2_drug product stability.pdfNovember 1, 20232 MB
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125742_S2_M2_drug product reference stand or materials.pdfNovember 1, 20232 MB
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125742_S2_M2_drug product description composition drug prod.pdfNovember 1, 20232 MB
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125742_S2_M2_appendices adv agen safe val.pdfNovember 1, 20232 MB
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125742_S1_M1_financial cert summary.pdfNovember 1, 2023715 KB
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125742_S1_M1_financial cert 3455.pdfNovember 1, 20232 MB
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125742_S1_M1_1.9.4_ipsp agreed.pdfNovember 1, 20232 MB
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125742_S1_M1_1.9.2_ped studies deferral req.pdfNovember 1, 202311 MB
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138_BLA_125742_STN125742 release test (pH) lots FD7220, FE3592, FF2587.pdfNovember 1, 20231 MB
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137_BLA_125742_Endotoxin release tests lots FD7220, FE3592, FF2587.pdfNovember 1, 2023813 KB
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125742_S2_M3_32s2_manufacturer.pdfNovember 1, 20232 MB
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125742_S2_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
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133_Courtesy Copy_BLA 125742 0_Benefit Risk Assessment Review Memo COMIRNATY.pdfNovember 1, 20233 MB
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132_BLA 125742 0_09 13 2021_Memo_Committee Memo_Review (1).pdfNovember 1, 20231 MB
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131_Courtesy Copy_BLA 125742 0_Clinical Review Memo, August 23, 2021 COMIRNATY.pdfNovember 1, 20231 MB
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129_BLA 125742 0_08 30 2021_Telecon_Other.pdfNovember 1, 2023638 KB
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128_BLA 125742 0_08 30 2021_Telecon_Other (1).pdfNovember 1, 2023637 KB
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127_Courtesy Copy_BLA 125742 0_CBER Sentinel Program Sufficiency Memo COMIRNATY.pdfNovember 1, 2023164 KB
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125_BLA 125742 0_08 23 2021_Memo_Committee Memo_Toxico.pdfNovember 1, 20234 MB
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124_BLA 125742 0_08 23 2021_Memo_Committee Memo_SBRA.pdfNovember 1, 20231 MB
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123_Courtesy Copy_BLA 125742 0_August 23, 2021 Approval Letter Comirnaty.pdfNovember 1, 2023157 KB
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122_BLA 125742 0_08 22 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023775 KB
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121_Courtesy Copy_BLA 125742 0_Employee Officer List Memo, August 22, 2021 COMIRNATY.pdfNovember 1, 202325 KB
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120_Courtesy Copy_BLA 125742 0_CBER CMC BLA Review Memo COMIRNATY.pdfNovember 1, 20231 MB
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119_Courtesy Copy_BLA 125742 0_Real World Evidence BLA Memo COMIRNATY.pdfNovember 1, 202363 KB
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118_1_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdfNovember 1, 2023659 KB
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117_2_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
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116_BLA 125742 0_08 21 2021_Inspection Related_Establi.pdfNovember 1, 20232 MB
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115_1_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023789 KB
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111_BLA 125742 0_08 21 2021_Telecon_Advice.pdfNovember 1, 2023660 KB
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110_1_Courtesy Copy_BLA 125742 0_Analytical Method Review Memo COMIRNATY.pdfNovember 1, 2023308 KB
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109_Courtesy Copy_2_BLA 125742 0_CMC Review Memo, August 21, 2021 COMIRNATY.pdfNovember 1, 2023839 KB
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136_BLA_125742_RNAcontent_InSupportTesting.pdfNovember 1, 2023739 KB
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135_Courtesy Copy_BLA 125742 0_November 8, 2021_Summary Basis for Regulatory Action COMIRNATY.pdfNovember 1, 2023540 KB
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134_Courtesy Copy_BLA 125742 0_Toxicology Review COMIRNATY.pdfNovember 1, 20234 MB
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107_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023806 KB
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105_BLA 125742 0_08 20 2021_Telecon_Advice_Information.pdfNovember 1, 2023761 KB
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103_2_BLA 125742 0_08 20 2021_Memo_Test Results.pdfNovember 1, 20231 MB
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102_1_BLA 125742 0_08 20 2021_Memo_Test Results.pdfNovember 1, 20231 MB
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101_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Addendum Memo COMIRNATY.pdfNovember 1, 2023145 KB
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100A_BLA 125742 0_08 20 2021_Memo_Other.pdfNovember 1, 20231 MB
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100_BLA 125742 0_08 20 2021_Memo_Other.pdfNovember 1, 20231 MB
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99_BLA 125742 0_08 20 2021_Memo_Committee Memo_Labeli.pdfNovember 1, 20232 MB
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95_BLA 125742 0_08 19 2021_Memo_Compliance Check Acce.pdfNovember 1, 20232 MB
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94_Courtesy Copy_1_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023261 KB
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93_Courtesy Copy_2_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023301 KB
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92_BLA 125742 0_08 19 2021_Inspection Related_Inspect.pdfNovember 1, 20232 MB
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89_1_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdfNovember 1, 2023743 KB
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87_3_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
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86_BLA 125742 0_08 18 2021_Telecon_Advice.pdfNovember 1, 2023984 KB
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85_Courtesy Copy_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023127 KB
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84_BLA 125742 0_08 18 2021_Memo_Committee Memo_Review.pdfNovember 1, 2023706 KB
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83_BLA 125742 0_08 17 2021_Telecon_Other.pdfNovember 1, 2023770 KB
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81_1_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfNovember 1, 2023760 KB
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79_3_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfNovember 1, 2023753 KB
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75_1_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 2023717 KB
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74_3_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 2023746 KB
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73_2_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
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68B_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023690 KB
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68A_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023710 KB
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68_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023753 KB
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66_4_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023794 KB
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65_BLA 125742 0_08 13 2021_Memo_Request For Complianc.pdfNovember 1, 2023864 KB
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64_Courtesy Copy_BLA 125742 0_Bioresearch Monitoring Discipline Review Memo, August 13, 2021 COMIRNATY.pdfNovember 1, 202381 KB
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62_BLA 125742 0_08 12 2021_Memo_Committee Memo_Requir.pdfNovember 1, 20231 MB
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108_BLA 125742 0_08 21 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
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107A_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023815 KB
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47_1_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdfNovember 1, 2023755 KB
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46_2_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdfNovember 1, 2023789 KB
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45_BLA 125742 0_08 05 2021_Telecon_Advice.pdfNovember 1, 2023801 KB
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44_3_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdfNovember 1, 2023767 KB
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43A_STN 125742.0 4AUG21 LRP FU IR 2.pdfNovember 1, 20232 MB
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42_1_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdfNovember 1, 2023773 KB
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40_2_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdfNovember 1, 2023772 KB
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39_2_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdfNovember 1, 2023784 KB
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33_1_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdfNovember 1, 2023734 KB
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32_1_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdfNovember 1, 2023890 KB
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27_BLA 125742 0_07 19 2021_Telecon_Advice.pdfNovember 1, 2023746 KB
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26_2_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdfNovember 1, 2023789 KB
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25_1_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdfNovember 1, 2023794 KB
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21_BLA 125742 0_07 15 2021_Letter_Filing Notification.pdfNovember 1, 2023722 KB
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18_BLA 125742 0_07 09 2021_Telecon_Information Reques.pdfNovember 1, 2023765 KB
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15_BLA 125742 0_07 02 2021_Telecon_Information Reques.pdfNovember 1, 2023819 KB
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10_BLA 125742 11_12 22 2021_Memo_Committee Memo_CMC.pdfNovember 1, 2023757 KB
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9_IND_19736_491_29 Sep 2021_DEBORAH_DEBORAH__RO_ The Summary Monthly Safety Report has been reviewed. No furthe.pdfNovember 1, 2023716 KB
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8_IND_19736_453_26 Aug 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023717 KB
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8_1_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
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7_IND_19736_409_26 Jul 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023718 KB
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6_IND_19736_366_24 Jun 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023717 KB
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5_IND_19736_335_19 May 2021_DEBORAH_DEBORAH__RC_.pdfNovember 1, 2023716 KB
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4_IND_19736_289_27 Apr 2021_DEBORAH_DEBORAH__RC_.pdfNovember 1, 2023717 KB
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3_IND_19736_243_19 Mar 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023696 KB
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3_BLA 125742 0_05 20 2021_Telecon_Information Reques.pdfNovember 1, 2023747 KB
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2_IND_19736_214_03 Mar 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023698 KB
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1_IND_19736_185_23 Feb 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023697 KB
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1_BLA 125742 0_05 13 2021_Letter_Acknowledgement Let.pdfNovember 1, 2023713 KB
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61_BLA 125742 0_08 11 2021_Telecon_Other.pdfNovember 1, 2023719 KB
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60_BLA 125742 0_08 11 2021_Telecon_Information Reques.pdfNovember 1, 2023764 KB
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58_2_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdfNovember 1, 2023755 KB
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55_BLA 125742 0_08 09 2021_Telecon_Advice.pdfNovember 1, 20232 MB
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54_BLA 125742 0_08 09 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
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53_2_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdfNovember 1, 2023765 KB
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52_1_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
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51_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Memo COMIRNATY.pdfNovember 1, 2023279 KB
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49_BLA 125742 0_08 06 2021_Letter_UNII Code Notificat.pdfNovember 1, 2023766 KB
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pd-production-110123.zipNovember 1, 2023337 MB
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md-production-110123.zipNovember 1, 202311 MB
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p1215d-production-110123.zipNovember 1, 202369 MB
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114_2_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023784 KB
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029 Order May 1, 2023 Status Conference (2023 04 21)April 21, 2023148 KB
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028 Plaintiff’s Reply in Support of Production Schedule (2023 04 12)April 12, 2023142 KB
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pd production 040323.zipApril 3, 2023196 MB
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125742_S1_M5_5314_vr mvr 10080 att 01.pdfApril 3, 20232 MB
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125742_S1_M5_5314_vr mvr 10080.pdfApril 3, 20232 MB
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125742_S1_M5_5314_vr mqr 10214 att 03.pdfApril 3, 20232 MB
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125742_S1_M5_5314_vr mqr 10214 att 02.pdfApril 3, 20232 MB
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125742_S1_M5_5314_vr mqr 10214 att 01.pdfApril 3, 20232 MB
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125742_S1_M5_5314_vr mqr 10212.pdfApril 3, 20232 MB
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125742_S1_M5_5314_vr mqr 10211 att 01.pdfApril 3, 20232 MB
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125742_S1_M5_5314_vr mqr 10211.pdfApril 3, 20232 MB
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125742_S14_M1_cover.pdfApril 3, 20232 MB
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125742_S7_M5_5351_bnt162 01 interim3 reports.pdfApril 3, 202325 MB
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125742_S4_M1_response 18 may 2021 datasets.pdfApril 3, 2023714 KB
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125742_S4_M1_cover.pdfApril 3, 2023675 KB
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125742_S3_M1_proprietary name.pdfApril 3, 20232 MB
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125742_S3_M1_cover.pdfApril 3, 2023705 KB
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125742_S2_M5_5354_wi255886 protocol.pdfApril 3, 20231 MB
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125742_S2_M5_5354_c4591022 protocol.pdfApril 3, 20233 MB
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125742_S2_M5_5354_c4591014 protocol.pdfApril 3, 20233 MB
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125742_S2_M5_5354_c4591012 protocol.pdfApril 3, 202315 MB
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125742_S2_M5_5354_c4591011 protocol.pdfApril 3, 20235 MB
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125742_S2_M5_5354_c4591009 protocol synopsis.pdfApril 3, 20232 MB
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125742_S2_M5_5354_c4591008 protocol.pdfApril 3, 20232 MB
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125742_S2_M5_5351_c4591015 protocol amend2.pdfApril 3, 202313 MB
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125742_S2_M5_5351_c4591007 protocol amend1.pdfApril 3, 202324 MB
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125742_S2_M1_pllr waiver request pregnancy registry.pdfApril 3, 20232 MB
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125742_S2_M1_pllr waiver request drug utilization.pdfApril 3, 20232 MB
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125742_S2_M1_pllr lit search summary.pdfApril 3, 20232 MB
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125742_S2_M1_pllr cumulative review.pdfApril 3, 20232 MB
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125742_S2_M1_loa dmf 9543 vials.pdfApril 3, 2023609 KB
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125742_S2_M1_diluent labeling proposal.pdfApril 3, 20232 MB
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125742_S2_M1_dca vaed.pdfApril 3, 2023744 KB
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125742_S2_M1_dca anaphylactic reaction.pdfApril 3, 2023724 KB
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125742_S2_M1_cover.pdfApril 3, 2023697 KB
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125742_S1_M5_5351_c4591001 interim mth6 synopsis.pdfApril 3, 20234 MB
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125742_S1_M5_5351_c4591001 interim mth6 report body.pdfApril 3, 202318 MB
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125742_S1_M5_5351_c4591001 fa interim synopsis.pdfApril 3, 20231 MB
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125742_S1_M5_5351_c4591001 fa interim report body.pdfApril 3, 202329 MB
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125742_S1_M5_5314_vr tm 10304.pdfApril 3, 20235 MB
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125742_S1_M5_5314_vr mvr 10083 att04.pdfApril 3, 20232 MB
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125742_S1_M5_5314_vr mvr 10083 att03.pdfApril 3, 20231 MB
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125742_S1_M5_5314_vr mvr 10083 att02.pdfApril 3, 20231 MB
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125742_S1_M5_5314_vr mvr 10083 att01.pdfApril 3, 20231 MB
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125742_S1_M5_5314_vr mvr 10081.pdfApril 3, 20232 MB
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125742_S1_M5_5314_vr mvr 10080 att 02.pdfApril 3, 20232 MB
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027 2 Declaration of Sarah B. Kotler (2023 03 31)March 31, 2023546 KB
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027 1 Declaration of Beth Brockner Ryan (2023 03 31)March 31, 2023511 KB
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027 Defendant Brief Regarding Production Schedule (2023 03 31)March 31, 2023424 KB
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024 Brief in Support of Timely Production Schedule (2023 03 08)March 8, 2023806 KB
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FDA CBER 2021 5683 0768093 0768158_125742_S1_M4_38166_define.zipMarch 1, 202328 KB
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FDA CBER 2021 5683 0768063 0768092_125742_S1_M4_20gr142_define2 0 0.zipMarch 1, 202314 KB
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FDA CBER 2021 5683 0771560 0771968_125742_S1_M4_20gr142 D_supplb.zipMarch 1, 202353 KB
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FDA CBER 2021 5683 0771520 0771559_125742_S1_M4_20gr142 D_suppfw.zipMarch 1, 20237 KB
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125742_S1_M4_4.2.3.2 38166.pdfMarch 1, 202321 MB
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pd production 030123.zipMarch 1, 202345 MB
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023 Order on Briefs (2023 02 23)February 23, 2023113 KB
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022 Joint Status Report (2023 02 17)February 17, 2023228 KB
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021 Order re Joint Scheduling Report [20], Next JSR Due February 17, 2023 (2023 02 07)February 7, 2023112 KB
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FDA CBER 2021 5683 0764726 125742_S1_M5_c4591001 S D di.zipFebruary 1, 20232 KB
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FDA CBER 2021 5683 0763794 0764725 125742_S1_M5_c4591001 A Supp D adae supp.zipFebruary 1, 20236 MB
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FDA CBER 2021 5683 0710059 0710068 125742_S1_M5_bnt162 01 S D co.zipFebruary 1, 202313 KB
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125742_S1_M4_4.2.2.4 01049 20010.pdfFebruary 1, 20232 MB
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125742_S1_M4_4.2.2.4 01049 20009.pdfFebruary 1, 20232 MB
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125742_S1_M2_2.6.7.1toxicology tabulated summary.pdfFebruary 1, 2023960 KB
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125742_S1_M2_2.6.6 toxicology written summary.pdfFebruary 1, 20232 MB
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125742_S1_M2_2.6.3.1 pharmacol tabulated summaryFebruary 1, 20232 MB
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125742_S1_M2_2.6.2 pharmacol written summary.pdfFebruary 1, 20237 MB
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125742_S1_M2_2.6.1 introduction.pdfFebruary 1, 20232 MB
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125742_S1_M4_4.3 munster jv 2020.pdfFebruary 1, 20233 MB
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125742_S1_M4_4.2.3.2 20gr142.pdfFebruary 1, 202318 MB
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125742_S1_M4_4.2.2.4 01049 20020.pdfFebruary 1, 20232 MB
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pd-production-020123.zipFebruary 1, 2023126 MB
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020 Joint Scheduling Report (2023 01 27)January 27, 2023225 KB
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019 ORDER re Conduct an in person Scheduling Conference and submit a Joint Status Report by Jan 27, 2023 (2023 0January 13, 2023177 KB
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017 Answer (2023 01 06)January 6, 2023192 KB
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FDA-CBER-2021-5683-0703843-0708840-125742_S1_M5_c4591001-S-Supp-D-suppae.xpt.zipJanuary 3, 2023845 KB
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125742_S41_M1_c4591001-ve-tables.pdfJanuary 3, 2023695 KB
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125742_S39_M1_5351_c4591001-ve-tables.pdfJanuary 3, 2023695 KB
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125742_S38_M5_c4591001-508-safety-tables.pdfJanuary 3, 2023928 KB
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125742_S28_M1_response-22jul2021-followup.pdfJanuary 3, 2023767 KB
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125742_S27_M1_response-29jul2021January 3, 20231 MB
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FDA-CBER-2021-5683-0652472-0652503-125742_S38_M5_c4591001-508-safety-tables.doc.docxJanuary 3, 202373 KB
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FDA-CBER-2021-5683-0652443-0652471-125742_S33_M5_5351_c4591001-508-efficacy-tables.doc.zipJanuary 3, 202353 KB
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125742_S21_M1_pvp-track.pdfJanuary 3, 20238 MB
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130_BLA _125742-0_09-01-2021_Committee Memo_Labeling.pdfJanuary 3, 2023771 KB
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FDA-CBER-2021-5683-0652385-0652413-125742_S29_M1_lab-1448-0-2-pkg-insert-clean.docxJanuary 3, 2023535 KB
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126_BLA 125742-0_08-23-2021_Memo_OtherJanuary 3, 2023649 KB
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125742_S80_M1_lab-1448-1-0-pkg-insert-clean.pdfJanuary 3, 2023875 KB
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114A_2_BLA_125742-0_08-21-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
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125742_S79_M1_lab-1448-1-0-pkg-insert-clean.pdfJanuary 3, 2023875 KB
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106A_2_BLA_125742-0_08-20-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
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98A_BLA_125742-0_08-19-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
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91A_2_BLA_125742-0_08-18-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
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82A_BLA_125742-0_08-17-2021_Telecon_Labeling via FAX_eJanuary 3, 20231 MB
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77_BLA_125742-0_08-17-2021_Memo_Lot Release Clearance.pdfJanuary 3, 2023805 KB
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72A_BLA_125742-0_08-13-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
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36A_BLA_125742-0_07-28-2021_Telecon_Labeling Target ClJanuary 3, 20231 MB
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13_BLA_125742-0_07-02-2021_Committee Memo_APLB.pdfJanuary 3, 2023848 KB
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10_BLA_125742-0_06-29-2021_Filing_Meeting_Summary.pdfJanuary 3, 2023713 KB
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7_BLA_125742-0_06-17-2021_Memo_Other.pdfJanuary 3, 2023682 KB
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4_BLA_125742-0_06-03-2021_First_Committee_Meeting_Summary.pdfJanuary 3, 2023772 KB
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22-00004-LT- Interim release.pdfSeptember 30, 202241 KB
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consolidated_health_checkin.csvSeptember 30, 202223 GB
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Consolidated_health_checkin_u3[1].csvSeptember 30, 202219 MB
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consolidated_vaccinations[1].zipSeptember 30, 2022151 MB
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consolidated_registrants[1].zipSeptember 30, 2022125 MB
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consolidated_race_ethnicity[1].zipSeptember 30, 202293 MB
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Consolidated_health_checkin_u3[1].zipSeptember 30, 20224 MB
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consolidated_health_checkin.zipSeptember 30, 20225 GB
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Amended 22-01962-Pfizer-2022-0426-pulled 2022-0823.xlsxSeptember 16, 202236 MB
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001 Complaint (PHMPT, de Garay v. FDA) (2022 10 11)September 11, 20225 MB
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FDA-CBER-2021-5683-0396255-0484341_125742_S1_M5_c4591001-S-Supp-D-suppface.xptSeptember 1, 2022467 MB
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pd-production-090122.zipSeptember 1, 202211 MB
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FDA CBER 2021 5683 0396249 0396254_125742_S1_M5_bnt162 01 S D xb.xptSeptember 1, 202243 KB
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FDA CBER 2021 5683 0396247 0396248_125742_S1_M5_bnt162 01 S D ta.xptSeptember 1, 202218 KB
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FDA CBER 2021 5683 0396242 0396246_125742_S1_M5_bnt162 01 S D suppxa.xptSeptember 1, 202224 KB
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FDA CBER 2021 5683 0396239 0396241_125742_S1_M5_bnt162 01 S D suppeg.xptSeptember 1, 202213 KB
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FDA CBER 2021 5683 0396234 0396238_125742_S1_M5_bnt162 01 S D suppdv.xptSeptember 1, 202256 KB
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FDA CBER 2021 5683 0396228 0396233_125742_S1_M5_bnt162 01 S D rp.xptSeptember 1, 202262 KB
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FDA CBER 2021 5683 0396223 0396227_125742_S1_M5_bnt162 01 S D dv.xptSeptember 1, 202267 KB
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FDA CBER 2021 5683 0396214 0396222_125742_S1_M5_bnt162 01 S D cm.xptSeptember 1, 2022200 KB
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FDA CBER 2021 5683 0396200 0396213_125742_S1_M5_bnt162 01 A D adae.xptSeptember 1, 2022804 KB
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FDA-CBER-2021-5683-0396199_125742_S1_M5_bnt162-01-S-D-tv.zipAugust 1, 20221 KB
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FDA CBER 2021 5683 0396198_125742_S1_M5_bnt162 01 S D te.xptAugust 1, 20227 KB
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FDA CBER 2021 5683 0396197_125742_S1_M5_bnt162 01 S D supprp.xptAugust 1, 20223 KB
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FDA CBER 2021 5683 0396196_125742_S1_M5_bnt162 01 S D supppe.xptAugust 1, 20226 KB
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FDA CBER 2021 5683 0396195_125742_S1_M5_bnt162 01 S D relrec.xptAugust 1, 20222 KB
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FDA CBER 2021 5683 0396193 to 0396194_125742_S1_M5_c4591001 S D supppe.xptAugust 1, 202212 KB
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FDA CBER 2021 5683 0396188 to 0396192_125742_S1_M5_c4591001 S D suppmo.xptAugust 1, 202265 KB
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FDA CBER 2021 5683 0396187_125742_S1_M5_c4591001 S D pr.xptAugust 1, 202219 KB
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FDA CBER 2021 5683 0396199_125742_S1_M5_bnt162 01 S D tv.xptAugust 1, 20224 KB
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FDA-CBER-2021-5683-0308157 to -0396186_125742_S1_M5_c4591001-S-D-suppface.xptAugust 1, 2022467 MB
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125742_S2_M5_54_ezeanolue e 2019.pdfAugust 1, 202240 MB
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22-01272-Pfizer-Shipped-2022-0426.xlsxJuly 25, 202215 MB
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22-01271-Pfizer-2022-0426.xlsxJuly 25, 20226 MB
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FDA CBER 2021 5683 0285652 to 0286071_125742_S1_M5_c4591001 S D pe.zip (xpt)July 1, 2022170 KB
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FDA CBER 2021 5683 0285644 to 0285651_125742_S1_M5_c4591001 S D mo.zip (xpt)July 1, 20226 KB
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FDA CBER 2021 5683 0282366 to 0285643_125742_S1_M5_c4591001 S D mb.zip (xpt)July 1, 20222 MB
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FDA CBER 2021 5683 0282329 to 0282365_125742_S1_M5_c4591001 S D ie.zip (xpt)July 1, 202219 KB
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FDA CBER 2021 5683 0282130 to 0282328_125742_S1_M5_c4591001 S D cm.zip (xpt)July 1, 2022151 KB
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FDA CBER 2021 5683 0225598 to 0282129_125742_S1_M5_c4591001 A Supp D adfacevd.zip (xpt)July 1, 202284 MB
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FDA CBER 2021 5683 0225100 to 0225597_125742_S1_M5_c4591001 A D adcm.zip (xpt)July 1, 20221 MB
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FDA CBER 2021 5683 0296904 to 0307543_125742_S1_M5_c4591001 S D suppce.zip (xpt)July 1, 20221 MB
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FDA CBER 2021 5683 0286267 to 0296903_125742_S1_M5_c4591001 S Supp D suppce.zip (xpt)July 1, 20221 MB
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FDA CBER 2021 5683 0286072 to 0286266_125742_S1_M5_c4591001 S Supp D relrec.zip (xpt)July 1, 202254 KB
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125742_S1_M5_5351_c4591001 interim mth6 lab measurements sensitive.pdfJuly 1, 20225 MB
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125742_S1_M5_5351_c4591001 interim mth6 interlab standard.pdfJuly 1, 202211 MB
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125742_S1_M5_5351_c4591001 interim mth6 excluded patients sensitive.pdfJuly 1, 20223 MB
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125742_S2_M5_5354_wi235284 protocol.pdfJuly 1, 202215 MB
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125742_S2_M1_right of reference.pdfJuly 1, 20222 MB
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125742_S1_M5_5351_c4591001 interim mth6 sap.pdfJuly 1, 20225 MB
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125742_S1_M5_5351_c4591001 interim mth6 protocol deviations.pdfJuly 1, 20222 MB
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125742_S1_M5_5351_c4591001 fa interim narrative sensitive.pdfJuly 1, 202219 MB
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FDA CBER 2021 5683 0208521 to 0216666_125742_S1_M5_c4591001 S Supp D suppvs.zip (xpt)June 1, 2022917 KB
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FDA CBER 2021 5683 0205318 to 0208520_125742_S1_M5_c4591001 S Supp D ex.zip (xpt)June 1, 20222 MB
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FDA CBER 2021 5683 0196049 to 0205317_125742_S1_M5_c4591001 S Supp D ce.zip (xpt)June 1, 20228 MB
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FDA CBER 2021 5683 0187906 to 0196048_125742_S1_M5_c4591001 S D suppvs.zip (xpt)June 1, 2022915 KB
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FDA CBER 2021 5683 0182981 to 0187905_125742_S1_M5_c4591001 S D suppmh.zip (xpt)June 1, 2022616 KB
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FDA CBER 2021 5683 0180191 to 0182980_125742_S1_M5_c4591001 S D suppis.zip (xpt)June 1, 2022350 KB
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FDA CBER 2021 5683 0178319 to 0180190_125742_S1_M5_c4591001 S D suppho.zip (xpt)June 1, 2022259 KB
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FDA CBER 2021 5683 0174607 to 0178318_125742_S1_M5_c4591001 S D suppdv.zip (xpt)June 1, 2022623 KB
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FDA CBER 2021 5683 0171524 to 0174606_125742_S1_M5_c4591001 S D suppds.zip (xpt)June 1, 2022405 KB
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FDA CBER 2021 5683 0169082 to 0171523_125742_S1_M5_c4591001 S D suppdm.zip (xpt)June 1, 2022334 KB
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FDA CBER 2021 5683 0168683 to 0169081_125742_S1_M5_c4591001 S D suppcm.zip (xpt)June 1, 202271 KB
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FDA CBER 2021 5683 0165893 to 0168682_125742_S1_M5_c4591001 S D is.zip (xpt)June 1, 20221 MB
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FDA CBER 2021 5683 0162690 to 0165892_125742_S1_M5_c4591001 S D ex.zip (xpt)June 1, 20222 MB
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FDA CBER 2021 5683 0159487 to 0162689_125742_S1_M5_c4591001 S D ec.zip (xpt)June 1, 20222 MB
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FDA CBER 2021 5683 0158560 to 0159486_125742_S1_M5_c4591001 S D dv.zip (xpt)June 1, 2022558 KB
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FDA CBER 2021 5683 0149082 to 0158559_125742_S1_M5_c4591001 S D ce.zip (xpt)June 1, 20228 MB
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FDA CBER 2021 5683 0142307 to 0149081_125742_S1_M5_c4591001 A Supp D adcevd.zip (xpt)June 1, 20228 MB
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125742_S1_M5_CRF_c4591001 1081 10811194 reissue.pdfJune 1, 20222 MB
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STN 125742 0 0 Section 2.5 Clinical Overview reissue.pdfJune 1, 20225 MB
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125742_S1_M5_CRF_c4591001 1128 11281009 reissue.pdfJune 1, 20222 MB
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125742_S1_M5_CRF_c4591001 1015 10151101.pdfJune 1, 20221 MB
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125742_S1_M5_CRF_c4591001 1015 10151089.pdfJune 1, 20221 MB
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125742_S1_M5_CRF_c4591001 1015 10151071.pdfJune 1, 20221 MB
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125742_S1_M5_CRF_c4591001 1013 10131517.pdfJune 1, 20221 MB
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125742_S1_M5_CRF_c4591001 1013 10131386.pdfJune 1, 20221,008 KB
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125742_S1_M5_CRF_c4591001 1013 10131255.pdfJune 1, 20221 MB
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125742_S1_M5_CRF_c4591001 1012 10121163.pdfJune 1, 20222 MB
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125742_S1_M5_CRF_c4591001 1008 10081603.pdfJune 1, 20221 MB
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125742_S1_M5_CRF_c4591001 1007 10071276.pdfJune 1, 20222 MB
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125742_S1_M5_CRF_c4591001 1007 10071280.pdfJune 1, 20222 MB
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125742_S1_M5_5351_c4591001 interim mth6 publications.pdfJune 1, 202211 MB
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125742_S1_M5_5351_c4591001 interim mth6 patient batches.pdfJune 1, 20221 MB
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125742_S1_M5_5351_c4591001 fa interim protocol deviations sensitive.pdfJune 1, 20222 MB
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125742_S1_M5_5351_c4591001 fa interim discontinued patients.pdfJune 1, 20223 MB
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125742_S1_M5_5351_c4591001 interim mth6 randomization.pdfJune 1, 20221 MB
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125742_S1_M5_5314_shi sop 10011.pdfJune 1, 20222 MB
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125742_S1_M2_summary biopharm.pdfJune 1, 20222 MB
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125742_S1_M5_5351_c4591001 fa interim adverse events.pdfJune 1, 202232 MB
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pd-production-060122.zipJune 1, 2022157 MB
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pd-production-050222.zipMay 2, 2022396 MB
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125742_S1_M5_5351_bnt162 01 interim3 invest signature.pdfMay 2, 2022634 KB
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125742_S1_M5_5351_bnt162 01 interim3 investigators.pdfMay 2, 20226 MB
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125742_S1_M5_5351_bnt162 01 interim3 iec irb.pdfMay 2, 20221 MB
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125742_S1_M5_5351_bnt162 01 interim3 excluded patients.pdfMay 2, 20222 MB
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125742_S1_M5_5351_bnt162 01 interim3 discontinued patients.pdfMay 2, 20222 MB
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125742_S1_M5_5351_bnt162 01 interim3 demographics.pdfMay 2, 20222 MB
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125742_S1_M5_5351_bnt162 01 interim3 compliance.pdfMay 2, 20227 MB
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125742_S1_M5_5351_bnt162 01_20242.pdfMay 2, 20222 MB
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125742_S1_M5_5351_bnt162 01_10010.pdfMay 2, 20221 MB
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125742_S1_M5_5351_bnt162 01 interim3 lab measurements.pdfMay 2, 202291 MB
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125742_S1_M5_5351_bnt162 01 interim3 report body.pdfMay 2, 202242 MB
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125742_S1_M5_5351_bnt162 01 interim3 protocol deviations.pdfMay 2, 20221 MB
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125742_S1_M5_5351_bnt162 01 interim3 protocol.pdfMay 2, 202210 MB
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125742_S1_M5_5351_bnt162 01 interim3 patient batches.pdfMay 2, 20223 MB
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125742_S1_M5_5351_bnt162 01 interim3 notes for reader.pdfMay 2, 20221 MB
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125742_S1_M5_5351_c4591001 interim mth6 sponsor signature.pdfMay 2, 202212 MB
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125742_S1_M5_5351_c4591001 interim mth6 sample crf.pdfMay 2, 20225 MB
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125742_S1_M5_5351_c4591001 interim mth6 randomization sensitive.pdfMay 2, 202265 MB
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125742_S1_M5_5351_bnt162 01 interim3 synopsis.pdfMay 2, 20224 MB
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125742_S1_M5_5351_bnt162 01 interim3 sponsor signature.pdfMay 2, 20222 MB
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125742_S1_M5_5351_bnt162 01 interim3 sponsor personnel list.pdfMay 2, 20222 MB
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125742_S1_M5_5351_bnt162 01 interim3 sap.pdfMay 2, 20223 MB
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125742_S1_M5_5351_bnt162 01 interim3 sample crf.pdfMay 2, 20229 MB
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125742_S1_M5_c4591001 S Supp acrf.pdfMay 2, 20223 MB
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125742_S1_M5_bnt162 01 S acrf.pdfMay 2, 20221 MB
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125742_S1_M5_bnt162 01 A adrg.pdfMay 2, 2022891 KB
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FDA CBER 2021 5683 0058955 to 0058999_125742_S1_M5_bnt162 01 S define 2 0 0.xslMay 2, 2022183 KB
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FDA CBER 2021 5683 0058829 to 0058954_125742_S1_M5_bnt162 01 S define.xmlMay 2, 2022985 KB
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FDA CBER 2021 5683 0058795 to 0058828_125742_S1_M5_bnt162 01 A define 2 0 0.xslMay 2, 2022183 KB
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FDA CBER 2021 5683 0058676 to 0058794_125742_S1_M5_bnt162 01 A define.xmlMay 2, 2022828 KB
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FDA CBER 2021 5683 0058653 to 0058675_125742_S1_M5_c4591001 S Supp define 2 0 0.xslMay 2, 2022183 KB
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FDA CBER 2021 5683 0058615 to 0058652_125742_S1_M5_c4591001 S Supp define.xmlMay 2, 2022300 KB
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FDA CBER 2021 5683 0058595 to 0058614_125742_S1_M5_c4591001 S define 2 0 0.xslMay 2, 2022183 KB
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FDA CBER 2021 5683 0058479 to 0058594_125742_S1_M5_c4591001 S define.xmlMay 2, 2022904 KB
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FDA CBER 2021 5683 0058459 to 0058478_125742_S1_M5_c4591001 A Supp define 2 0 0.xslMay 2, 2022183 KB
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FDA CBER 2021 5683 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xmlMay 2, 2022692 KB
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FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xptMay 2, 202244 MB
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FDA-CBER-2021-5683-0066701-to-0123167_125742_S1_M5_c4591001-A-D-adfacevd.zip (.xpt)May 2, 202279 MB
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FDA-CBER-2021-5683-0123168-to-0126026_125742_S1_M5_c4591001-A-D-adva.zip (.xpt)May 2, 20226 MB
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reissue_5.3.6 postmarketing experience.pdfApril 1, 2022958 KB
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125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdfApril 1, 20221 MB
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125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdfApril 1, 202228 MB
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125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdfApril 1, 20221 MB
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125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdfApril 1, 20221 MB
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125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdfApril 1, 20222 MB
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125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdfApril 1, 20225 MB
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125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdfApril 1, 202259 MB
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125742_S1_M5_5351_c4591001-fa-interim-randomization.pdfApril 1, 20222 MB
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125742_S1_M5_5351_c4591001-fa-interim-publications.pdfApril 1, 202210 MB
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125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdfApril 1, 20221 MB
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125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdfApril 1, 2022677 KB
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125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdfApril 1, 20228 MB
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125742_S1_M5_5351_c4591001-fa-interim-demographics.pdfApril 1, 202228 MB
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125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdfApril 1, 2022869 KB
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pd-production-040122.zipApril 1, 2022128 MB
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pd-production-032422.zipMarch 24, 20222 MB
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125742_S1_M1_priority-review-request.pdfMarch 24, 20222 MB
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125742_S1_M1_priority-review-request.pdfMarch 24, 20222 MB
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cd-production-031622.zipMarch 17, 2022101 KB
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034 – Transcript of Scheduling Conference (December 14, 2021).pdfMarch 17, 2022141 KB
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FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsxMarch 1, 202217 KB
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FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsxMarch 1, 202212 KB
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FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsxMarch 1, 202210 KB
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FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsxMarch 1, 202210 KB
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FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsxMarch 1, 20229 KB
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FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsxMarch 1, 20229 KB
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FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsxMarch 1, 202210 KB
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FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsxMarch 1, 202212 KB
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FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsxMarch 1, 202235 KB
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FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsxMarch 1, 202223 KB
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FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsxMarch 1, 202284 KB
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FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsxMarch 1, 202222 KB
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FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsxMarch 1, 202219 KB
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FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsxMarch 1, 202218 KB
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FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsxMarch 1, 202229 KB
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FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsxMarch 1, 202213 KB
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FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsxMarch 1, 202221 KB
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FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsxMarch 1, 202224 KB
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FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsxMarch 1, 202211 KB
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FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsxMarch 1, 202212 KB
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FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsxMarch 1, 202212 KB
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FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsxMarch 1, 20229 KB
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FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsxMarch 1, 20229 KB
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FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsxMarch 1, 202210 KB
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FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsxMarch 1, 20229 KB
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FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsxMarch 1, 202214 KB
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FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xslMarch 1, 2022183 KB
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FDA-CBER-2021-5683-0023150 to -0023454_125742_S1_M5_c4591001-A-define.xmlMarch 1, 20221 MB
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FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txtMarch 1, 2022197 KB
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FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txtMarch 1, 202275 KB
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FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txtMarch 1, 202229 KB
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FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txtMarch 1, 202275 KB
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FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txtMarch 1, 202275 KB
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FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txtMarch 1, 202224 KB
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FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txtMarch 1, 202249 KB
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FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txtMarch 1, 202211 KB
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FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txtMarch 1, 202245 KB
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FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txtMarch 1, 202243 KB
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FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txtMarch 1, 202272 KB
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FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txtMarch 1, 202212 KB
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FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txtMarch 1, 202219 KB
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FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txtMarch 1, 202220 KB
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FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txtMarch 1, 202281 KB
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FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas.txtMarch 1, 202218 KB
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FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas.txtMarch 1, 202235 KB
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FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas.txtMarch 1, 202215 KB
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FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txtMarch 1, 202215 KB
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FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txtMarch 1, 202215 KB
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FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txtMarch 1, 202214 KB
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FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txtMarch 1, 2022156 KB
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FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txtMarch 1, 202232 KB
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FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txtMarch 1, 202227 KB
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FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txtMarch 1, 2022193 KB
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125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdfMarch 1, 20222 MB
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125742_S1_M5_c4591001-A-report-cci-rheumatic.pdfMarch 1, 2022629 KB
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125742_S1_M5_c4591001-A-report-cci-renal.pdfMarch 1, 2022629 KB
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125742_S1_M5_c4591001-A-report-cci-pulmonary.pdfMarch 1, 2022630 KB
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125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdfMarch 1, 2022632 KB
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125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdfMarch 1, 2022625 KB
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125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdfMarch 1, 2022626 KB
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125742_S1_M5_CRF_c4591001-1085-10851246.pdfMarch 1, 20221 MB
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125742_S1_M5_CRF_c4591001-1085-10851216.pdfMarch 1, 20221 MB
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125742_S1_M5_CRF_c4591001-1085-10851129.pdfMarch 1, 20222 MB
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125742_S1_M5_CRF_c4591001-1085-10851116.pdfMarch 1, 20221 MB
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125742_S1_M5_CRF_c4591001-1085-10851018.pdfMarch 1, 20222 MB
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125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdfMarch 1, 202217 MB
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125742_S1_M5_c4591001-T-S-suppl-arg.pdfMarch 1, 2022738 KB
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125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdfMarch 1, 2022667 KB
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125742_S1_M5_c4591001-T-S-roadmap.pdfMarch 1, 2022703 KB
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125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdfMarch 1, 2022627 KB
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125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdfMarch 1, 2022626 KB
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125742_S1_M5_c4591001-A-report-cci-dementia.pdfMarch 1, 2022626 KB
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125742_S1_M5_c4591001-A-report-cci-chf.pdfMarch 1, 2022628 KB
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125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdfMarch 1, 2022632 KB
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125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdfMarch 1, 2022670 KB
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125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdfMarch 1, 2022629 KB
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125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdfMarch 1, 2022846 KB
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125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdfMarch 1, 2022607 KB
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125742_S1_M5_c4591001-A-comorbidity-categories.pdfMarch 1, 2022637 KB
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125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdfMarch 1, 2022620 KB
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125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdfMarch 1, 2022634 KB
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125742_S1_M5_c4591001-A-report-cci-mild-liver.pdfMarch 1, 2022628 KB
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125742_S1_M5_c4591001-A-report-cci-mi.pdfMarch 1, 2022624 KB
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125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdfMarch 1, 2022636 KB
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125742_S1_M5_c4591001-A-report-cci-lymphoma.pdfMarch 1, 2022640 KB
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125742_S1_M5_c4591001-A-report-cci-leukemia.pdfMarch 1, 2022631 KB
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125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdfMarch 1, 2022626 KB
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125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdfMarch 1, 202237 MB
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125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdfMarch 1, 202213 MB
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125742_S1_M5_5351_c4591001-fa-interim-protocol.pdfMarch 1, 202231 MB
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125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdfMarch 1, 20222 MB
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125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdfMarch 1, 20225 MB
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125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdfMarch 1, 202212 MB
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125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdfMarch 1, 202216 MB
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125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdfMarch 1, 20222 MB
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125742_S1_M5_5351_c4591001-fa-interim-errata.pdfMarch 1, 20222 MB
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125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdfMarch 1, 20222 MB
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125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdfMarch 1, 20221 MB
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125742_S1_M5_5351_c4591001-fa-interim-compliance.pdfMarch 1, 20222 MB
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125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdfMarch 1, 2022889 KB
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125742_S1_M5_c4591001-A-bmi-12-15-scale.pdfMarch 1, 2022627 KB
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125742_S1_M5_c4591001-A-adrg.pdfMarch 1, 20222 MB
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125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdfMarch 1, 2022602 KB
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125742_S1_M1_us-agent-authorization.pdfMarch 1, 20221 MB
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125742_S1_M1_trans-of-oblig.pdfMarch 1, 2022717 KB
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125742_S1_M1_ipsp-agreed-letter.pdfMarch 1, 2022658 KB
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125742_S1_M1_financial-cert-bias.pdfMarch 1, 2022696 KB
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125742_S1_M1_financial-cert-3454.pdfMarch 1, 20223 MB
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125742_S1_M1_fast-track-designation.pdfMarch 1, 2022649 KB
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125742_S1_M1_exclusivity-claim.pdfMarch 1, 2022616 KB
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125742_S1_M1_debarment.pdfMarch 1, 2022656 KB
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125742_S1_M1_cover.pdfMarch 1, 20221 MB
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125742_S1_M1_3674.pdfMarch 1, 20225 MB
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125742_S1_M1_356h.pdfMarch 1, 2022714 KB
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125742_S1_M4_4223_R-20-0072.pdfMarch 1, 20225 MB
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125742_S1_M4_4223_185350.pdfMarch 1, 20221 MB
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125742_S1_M2_27_synopses-indiv-studies.pdfMarch 1, 20222 MB
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125742_S1_M2_27_literature-references.pdfMarch 1, 20222 MB
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125742_S1_M2_26_pharmkin-written-summary.pdfMarch 1, 20221 MB
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125742_S1_M2_26_pharmkin-tabulated-summary.pdfMarch 1, 20221 MB
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125742_S1_M2_24_nonclinical-overview.pdfMarch 1, 20222 MB
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125742_S1_M2_22_introduction.pdfMarch 1, 2022670 KB
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125742_S1_M1_waiver-req-designated-suffix.pdfMarch 1, 20223 MB
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125742_S1_M1_userfee.pdfMarch 1, 2022628 KB
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pd-production-030122.zipMarch 1, 2022195 MB
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Order-February-7-2022.pdfFebruary 7, 2022151 KB
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cd-production-020722.zipFebruary 7, 2022151 KB
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056-ORDER-GRANTING-IN-PART-THE-MOTION-TO-MODIFY-THE-PRODUCTION-SCHEDULE-AND-ADDOPTS-THE-JOINT-STATUS-REPORT-MODIFIED-AGREED-PRODUCTION-SCHEDULE.pdfFebruary 2, 2022124 KB
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cd-production-020222.zipFebruary 2, 2022125 KB
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CRFs-for-site-1128.pdfJanuary 31, 202214 MB
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pd-production-013122.zipJanuary 31, 202214 MB
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047-PLAINTIFFS-RESPONSE-TO-PFIZER-INC.S-MOTION-FOR-LEAVE-TO-INTERVENE-FOR-A-LIMITED-PURPOSE.pdfJanuary 25, 2022293 KB
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046-RESPONSE-filed-by-Food-and-Drug-Administration-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdfJanuary 25, 2022128 KB
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cd-production-012522.zipJanuary 25, 2022422 KB
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044-PL-PHPMTS-MOL-IN-OPPOSITION-TO-DEFENDANTS-MOTION-TO-MODIFY-THE-SCHEDULING-ORDER-OF-THE-COURT.pdfJanuary 24, 2022420 KB
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cd-production-012422.zipJanuary 24, 2022420 KB
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041-Memorandum-in-Support-filed-by-Pfizer-Inc.-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdfJanuary 21, 20221,014 KB
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cd-production-012122.zipJanuary 21, 20221,014 KB
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CRFs-for-site-1096.pdfJanuary 18, 202211 MB
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038-Appendix-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order.pdfJanuary 18, 20221 MB
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037-Brief-Memorandum-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order-1.pdfJanuary 18, 2022247 KB
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pd-production-011822.zipJanuary 18, 202211 MB
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cd-production-011822.zipJanuary 18, 20221 MB
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ORDER_2022_01_06.pdfJanuary 6, 2022169 KB
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cd-production-010622.zipJanuary 6, 2022170 KB
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CRFs-for-site-1081.pdfDecember 30, 202113 MB
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pd-production-123021.zipDecember 30, 202113 MB
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Supplemental-Index-12-22-21.pdfDecember 22, 20212 MB
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STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdfDecember 13, 20216 MB
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STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdfDecember 13, 20213 MB
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STN-125742_0_0-Section-2.5-Clinical-Overview.pdfDecember 13, 20214 MB
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signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdfDecember 13, 2021207 KB
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CRFs-for-site-1055.pdfDecember 13, 20216 MB
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BATES-FDA-CBER-2021-5683-0002380_ti.xptDecember 13, 202137 KB
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BATES-FDA-CBER-2021-5683-0002378_ta.xptDecember 13, 20218 KB
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BATES-FDA-CBER-2021-5683-0002375_addv-sas.txtDecember 13, 20215 KB
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BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txtDecember 13, 20219 KB
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BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
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BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
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032-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-31-Reply.pdfDecember 13, 202124 MB
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030-FDAs-Appendix-in-Support-of-Brief.pdfDecember 13, 20211 MB
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029-FDAs-Reply-re-Brief-in-Support-of-Motion.pdfDecember 13, 2021280 KB
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pd-production-121321.zipDecember 13, 202121 MB
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027-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-26-Brief-Memorandum-in-Support-of-Motion.pdfDecember 7, 202116 MB
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026-Brief-Memorandum-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-21-Order-Setting-DeadlineHearing.pdfDecember 7, 2021239 KB
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cd-production-120721.zipDecember 7, 202117 MB
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022-FDA-Brief-in-Advance-of-Scheduling-Conference.pdfDecember 6, 2021273 KB
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Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdfDecember 1, 202114 MB
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Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdfDecember 1, 202112 MB
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BATES-93_tv.xptNovember 17, 202116 KB
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5.2-tabular-listing.pdfNovember 17, 20212 MB
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5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdfNovember 17, 20218 MB
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BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txtNovember 17, 20219 KB
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5.3.6-postmarketing-experience.pdfNovember 17, 2021984 KB
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111521-Second-Joint-Status-Report.pdfNovember 15, 2021382 KB
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091621-Complaint.pdfSeptember 16, 20211 MB
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