Pfizer 16+ Documents

Four days after the Pfizer vaccine was approved for ages 16+, PHMPT submitted a Freedom of Information Act Request to the FDA for all of the data within Pfizer’s COVID-19 vaccine biological product file. PHMPT has now sued the FDA for not releasing the data. Click below for court documents and for productions of Pfizer’s documents from the FDA.

TitleDateFile SizeLink
125742 0_20219001.P0.pdfNovember 1, 2023912 KB
125742_S112_S2_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
125742_S116_M1_lab 1448 1 0.pdfNovember 1, 20231 MB
125742_S112_M1_cover.pdfNovember 1, 20232 MB
125742_S111_M1_cover.pdfNovember 1, 20232 MB
125742_S111_M1_letter of authorization.pdfNovember 1, 2023739 KB
125742_S111_M1_356h.pdfNovember 1, 20234 MB
125742_S80_M1_cover.pdfNovember 1, 2023734 KB
125742_S63_M1_response 18aug2021.pdfNovember 1, 20232 MB
125742_S61_M1_response 17aug2021.pdfNovember 1, 20232 MB
125742_S63_M1_cover.pdfNovember 1, 20232 MB
125742_S60_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
125742_S61_M1_cover.pdfNovember 1, 2023668 KB
125742_S60_M1_response 17aug2021.pdfNovember 1, 20232 MB
125742_S59_M1_response 17aug2021.pdfNovember 1, 20231 MB
125742_S60_M1_cover.pdfNovember 1, 20232 MB
125742_S57_M3_32p3_manufacturer diluent.pdfNovember 1, 20232 MB
125742_S59_M1_cover.pdfNovember 1, 2023672 KB
125742_S57_M1_response 16aug2021.pdfNovember 1, 20232 MB
125742 0_20219009.P0.pdfNovember 1, 2023889 KB
FDA CBER 2021 5683 1150835 1200874_Slipsheet.pdfNovember 1, 202369 KB
STN 124742_Courtesy Copy_Pfizer BioNTech Comirnaty STN 125742 COVID 19 Vaccine Lot Notifications (2021).pdfNovember 1, 2023200 KB
125742 0_20219007.P0.pdfNovember 1, 2023832 KB
125742 0_20219008.P0.pdfNovember 1, 2023882 KB
125742 0_20219006.P0.pdfNovember 1, 2023902 KB
125742 0_20219006.PC1.pdfNovember 1, 2023902 KB
125742 0_20219004.P0.pdfNovember 1, 2023903 KB
125742 0_20219005.P0.pdfNovember 1, 2023898 KB
125742 0_20219003.P0.pdfNovember 1, 2023897 KB
125742 0_20219003.PC1.pdfNovember 1, 2023898 KB
125742 0_20219002.P0.pdfNovember 1, 2023905 KB
125742 0_20219002.PC1.pdfNovember 1, 2023905 KB
125742 0_20219001.PC1.pdfNovember 1, 2023912 KB
125742_S56_M1_response 13aug2021.pdfNovember 1, 20232 MB
125742_S55_M3_32p8_stability summary.pdfNovember 1, 20233 MB
125742_S56_M1_cover.pdfNovember 1, 2023672 KB
125742_S55_M3_32p8_stability data long term.pdfNovember 1, 20233 MB
125742_S55_M2_introduction.pdfNovember 1, 202311 MB
125742_S55_M2_drug product stability.pdfNovember 1, 20233 MB
125742_S55_M2_32p8_stability data accelerated.pdfNovember 1, 20233 MB
125742_S53_M1_response 13aug2021.pdfNovember 1, 20231 MB
125742_S55_M1_cover.pdfNovember 1, 2023767 KB
125742_S50_M3_32r_comirnaty lot release template.pdfNovember 1, 20232 MB
125742_S53_M1_cover.pdfNovember 1, 2023675 KB
125742_S50_M1_response 13aug2021.pdfNovember 1, 20232 MB
125742_S48_M1_response 06aug2021.pdfNovember 1, 20232 MB
125742_S50_M1_cover.pdfNovember 1, 20232 MB
125742_S48_M1_cover.pdfNovember 1, 20232 MB
125742_S47_M1_response 11aug2021.pdfNovember 1, 20232 MB
125742_S47_M3_32p3_manufacturer diluent.pdfNovember 1, 20232 MB
125742_S47_M1_cover.pdfNovember 1, 20232 MB
125742_S44_M1_response 10aug2021.pdfNovember 1, 20232 MB
125742_S43_M3_32p3_manufacturers.pdfNovember 1, 20232 MB
125742_S44_M1_cover.pdfNovember 1, 20232 MB
125742_S43_M1_response 05aug2021.pdfNovember 1, 20232 MB
125742_S42_M3_32r_comirnaty lot release template.pdfNovember 1, 2023709 KB
125742_S43_M1_cover.pdfNovember 1, 20232 MB
125742_S42_M1_response 04aug2021.pdfNovember 1, 20234 MB
125742_S40_M1_response 06aug2021.pdfNovember 1, 20232 MB
125742_S42_M1_cover.pdfNovember 1, 20232 MB
125742_S40_M1_cover.pdfNovember 1, 20232 MB
125742_S37_M1_cover.pdfNovember 1, 20232 MB
125742_S37_M1_response 05aug2021.pdfNovember 1, 20232 MB
125742_S36_M1_response 02aug2021.pdfNovember 1, 20232 MB
125742_S35_M1_response 04aug2021.pdfNovember 1, 20231 MB
125742_S36_M1_cover.pdfNovember 1, 20232 MB
125742_S35_M1_cover.pdfNovember 1, 20232 MB
125742_S34_M1_response 03aug2021.pdfNovember 1, 20231 MB
125742_S34_M3_32a3_excipient information nomenclature alc 0315.pdfNovember 1, 20232 MB
125742_S57_M1_cover.pdfNovember 1, 20232 MB
125742_S26_M1_fda bnt cl.pdfNovember 1, 2023996 KB
125742_S30_M1_cover.pdfNovember 1, 2023671 KB
125742_S26_M1_andover 483 response.pdfNovember 1, 20231 MB
125742_S26_M1_cover.pdfNovember 1, 2023718 KB
125742_S25_M1_response 26jul2021.pdfNovember 1, 20231 MB
125742_S22_M1_response 16jul2021.pdfNovember 1, 20231 MB
125742_S25_M1_cover.pdfNovember 1, 2023668 KB
125742_S19_M1_response 02jul2021.pdfNovember 1, 20232 MB
125742_S22_M1_cover.pdfNovember 1, 2023678 KB
125742_S19_M1_cover.pdfNovember 1, 20232 MB
125742_S17_M1_cover.pdfNovember 1, 2023674 KB
125742_S17_M1_reponse 09jul2021.pdfNovember 1, 20232 MB
125742_S15_M1_response 16jul2021 lrp samples.pdfNovember 1, 20231 MB
125742_S15_M3_32r_comirnaty lot release 16jul2021.pdfNovember 1, 20231 MB
125742_S11_M3_32r_pf 07302048 dp rm coa.pdfNovember 1, 2023634 KB
125742_S15_M1_cover.pdfNovember 1, 2023675 KB
125742_S11_M3_32r_fc3184 coa.pdfNovember 1, 2023836 KB
125742_S11_M3_32r_fd0809 coa.pdfNovember 1, 2023836 KB
125742_S11_M3_32r_677365 1g a 010 coa.pdfNovember 1, 2023636 KB
125742_S11_M3_32r_fc3181 coa.pdfNovember 1, 2023840 KB
125742_S11_M3_32r_677100p 1g a 010 coa.pdfNovember 1, 2023636 KB
125742_S11_M3_32r_677159p 1g a 010 coa.pdfNovember 1, 2023636 KB
125742_S11_M3_32r_677315o 1g a 010 coa.pdfNovember 1, 2023635 KB
125742_S11_M3_32r_21y513c2401 coa.pdfNovember 1, 20231 MB
125742_S11_M3_32r_21y513c2501 coa.pdfNovember 1, 2023636 KB
125742_S11_M1_response 25jun2021 cmc.pdfNovember 1, 20232 MB
125742_S11_M3_32r_21y513c2301 coa.pdfNovember 1, 20231 MB
125742_S11_M1_cover.pdfNovember 1, 20232 MB
125742_S5_M1_cover.pdfNovember 1, 2023725 KB
125742_S5_M1_response 20 may 2021 facilities.pdfNovember 1, 20231 MB
125742_S2_M3_32s4_specification.pdfNovember 1, 20232 MB
125742_S2_M3_32s4_validation analyt procedure overview.pdfNovember 1, 20232 MB
125742_S2_M3_32s4_analytical procedure overview.pdfNovember 1, 20232 MB
125742_S30_M1_response 26jul2021.pdfNovember 1, 20231 MB
125742_S34_M1_cover.pdfNovember 1, 2023668 KB
125742_S2_M3_32r_reg info manufacturing schedules.pdfNovember 1, 20232 MB
125742_S2_M3_32r_reg info lot release documentation package.pdfNovember 1, 20234 MB
125742_S2_M3_32p53_validation analytical procedure rt pcr.pdfNovember 1, 20232 MB
125742_S2_M3_32p53_validation analytical procedures overview.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure subvis particulate matter.pdfNovember 1, 20232 MB
125742_S2_M3_32p53_validation analytical procedure cap gel electro.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure rt pcr.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure osmometry.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure overview.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure endotoxin.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_stability summary.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure cap gel electro.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_stability data thermal stress cycling.pdfNovember 1, 20233 MB
125742_S2_M3_32p8_stability data photostability.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_stability data long term.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_stability data accelerated.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_postapproval stability.pdfNovember 1, 20232 MB
125742_S2_M3_32p5_batch analyses.pdfNovember 1, 20233 MB
125742_S2_M3_32p5_specifications.pdfNovember 1, 20232 MB
125742_S2_M3_32p4_novel excipients.pdfNovember 1, 20232 MB
125742_S2_M3_32p4_excipients human animal.pdfNovember 1, 20232 MB
125742_S2_M3_32p3_control critical steps in process mon control overview.pdfNovember 1, 20232 MB
125742_S2_M3_32p3_manufacturers.pdfNovember 1, 20232 MB
125742_S2_M3_32p3_batch formula.pdfNovember 1, 20232 MB
125742_S2_M3_32p1_description and composition.pdfNovember 1, 20232 MB
125742_S2_M3_32p2_pharmaceutical development introduction.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information structure alc 0159.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information structure alc 0315.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information nomenclature alc 0315.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information nomenclature alc 0159.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information excipients alc 0159.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information excipients alc 0315.pdfNovember 1, 20232 MB
125742_S2_M3_32a2_adventitious agents kalamazoo.pdfNovember 1, 20232 MB
125742_S2_M3_32a2_adventitious agents puurs.pdfNovember 1, 20232 MB
125742_S2_M3_32a2_adventitious agents andover.pdfNovember 1, 20232 MB
125742_S2_M2_drug product stability.pdfNovember 1, 20232 MB
125742_S2_M2_introduction.pdfNovember 1, 20232 MB
125742_S2_M2_drug product reference stand or materials.pdfNovember 1, 20232 MB
125742_S2_M2_appendices adv agen safe val.pdfNovember 1, 20232 MB
125742_S2_M2_drug product description composition drug prod.pdfNovember 1, 20232 MB
125742_S1_M1_financial cert 3455.pdfNovember 1, 20232 MB
125742_S1_M1_financial cert summary.pdfNovember 1, 2023715 KB
125742_S1_M1_1.9.4_ipsp agreed.pdfNovember 1, 20232 MB
125742_S1_M1_1.9.2_ped studies deferral req.pdfNovember 1, 202311 MB
138_BLA_125742_STN125742 release test (pH) lots FD7220, FE3592, FF2587.pdfNovember 1, 20231 MB
137_BLA_125742_Endotoxin release tests lots FD7220, FE3592, FF2587.pdfNovember 1, 2023813 KB
125742_S2_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
125742_S2_M3_32s2_manufacturer.pdfNovember 1, 20232 MB
133_Courtesy Copy_BLA 125742 0_Benefit Risk Assessment Review Memo COMIRNATY.pdfNovember 1, 20233 MB
131_Courtesy Copy_BLA 125742 0_Clinical Review Memo, August 23, 2021 COMIRNATY.pdfNovember 1, 20231 MB
132_BLA 125742 0_09 13 2021_Memo_Committee Memo_Review (1).pdfNovember 1, 20231 MB
127_Courtesy Copy_BLA 125742 0_CBER Sentinel Program Sufficiency Memo COMIRNATY.pdfNovember 1, 2023164 KB
128_BLA 125742 0_08 30 2021_Telecon_Other (1).pdfNovember 1, 2023637 KB
129_BLA 125742 0_08 30 2021_Telecon_Other.pdfNovember 1, 2023638 KB
125_BLA 125742 0_08 23 2021_Memo_Committee Memo_Toxico.pdfNovember 1, 20234 MB
123_Courtesy Copy_BLA 125742 0_August 23, 2021 Approval Letter Comirnaty.pdfNovember 1, 2023157 KB
124_BLA 125742 0_08 23 2021_Memo_Committee Memo_SBRA.pdfNovember 1, 20231 MB
120_Courtesy Copy_BLA 125742 0_CBER CMC BLA Review Memo COMIRNATY.pdfNovember 1, 20231 MB
121_Courtesy Copy_BLA 125742 0_Employee Officer List Memo, August 22, 2021 COMIRNATY.pdfNovember 1, 202325 KB
122_BLA 125742 0_08 22 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023775 KB
118_1_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdfNovember 1, 2023659 KB
119_Courtesy Copy_BLA 125742 0_Real World Evidence BLA Memo COMIRNATY.pdfNovember 1, 202363 KB
116_BLA 125742 0_08 21 2021_Inspection Related_Establi.pdfNovember 1, 20232 MB
117_2_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
111_BLA 125742 0_08 21 2021_Telecon_Advice.pdfNovember 1, 2023660 KB
115_1_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023789 KB
136_BLA_125742_RNAcontent_InSupportTesting.pdfNovember 1, 2023739 KB
109_Courtesy Copy_2_BLA 125742 0_CMC Review Memo, August 21, 2021 COMIRNATY.pdfNovember 1, 2023839 KB
110_1_Courtesy Copy_BLA 125742 0_Analytical Method Review Memo COMIRNATY.pdfNovember 1, 2023308 KB
134_Courtesy Copy_BLA 125742 0_Toxicology Review COMIRNATY.pdfNovember 1, 20234 MB
135_Courtesy Copy_BLA 125742 0_November 8, 2021_Summary Basis for Regulatory Action COMIRNATY.pdfNovember 1, 2023540 KB
107_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023806 KB
103_2_BLA 125742 0_08 20 2021_Memo_Test Results.pdfNovember 1, 20231 MB
105_BLA 125742 0_08 20 2021_Telecon_Advice_Information.pdfNovember 1, 2023761 KB
101_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Addendum Memo COMIRNATY.pdfNovember 1, 2023145 KB
102_1_BLA 125742 0_08 20 2021_Memo_Test Results.pdfNovember 1, 20231 MB
100_BLA 125742 0_08 20 2021_Memo_Other.pdfNovember 1, 20231 MB
100A_BLA 125742 0_08 20 2021_Memo_Other.pdfNovember 1, 20231 MB
95_BLA 125742 0_08 19 2021_Memo_Compliance Check Acce.pdfNovember 1, 20232 MB
99_BLA 125742 0_08 20 2021_Memo_Committee Memo_Labeli.pdfNovember 1, 20232 MB
93_Courtesy Copy_2_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023301 KB
94_Courtesy Copy_1_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023261 KB
89_1_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdfNovember 1, 2023743 KB
92_BLA 125742 0_08 19 2021_Inspection Related_Inspect.pdfNovember 1, 20232 MB
86_BLA 125742 0_08 18 2021_Telecon_Advice.pdfNovember 1, 2023984 KB
87_3_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
84_BLA 125742 0_08 18 2021_Memo_Committee Memo_Review.pdfNovember 1, 2023706 KB
85_Courtesy Copy_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023127 KB
79_3_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfNovember 1, 2023753 KB
81_1_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfNovember 1, 2023760 KB
83_BLA 125742 0_08 17 2021_Telecon_Other.pdfNovember 1, 2023770 KB
74_3_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 2023746 KB
75_1_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 2023717 KB
68B_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023690 KB
73_2_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
68_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023753 KB
68A_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023710 KB
65_BLA 125742 0_08 13 2021_Memo_Request For Complianc.pdfNovember 1, 2023864 KB
66_4_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023794 KB
62_BLA 125742 0_08 12 2021_Memo_Committee Memo_Requir.pdfNovember 1, 20231 MB
64_Courtesy Copy_BLA 125742 0_Bioresearch Monitoring Discipline Review Memo, August 13, 2021 COMIRNATY.pdfNovember 1, 202381 KB
107A_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023815 KB
108_BLA 125742 0_08 21 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
47_1_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdfNovember 1, 2023755 KB
45_BLA 125742 0_08 05 2021_Telecon_Advice.pdfNovember 1, 2023801 KB
46_2_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdfNovember 1, 2023789 KB
43A_STN 125742.0 4AUG21 LRP FU IR 2.pdfNovember 1, 20232 MB
44_3_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdfNovember 1, 2023767 KB
40_2_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdfNovember 1, 2023772 KB
42_1_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdfNovember 1, 2023773 KB
33_1_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdfNovember 1, 2023734 KB
39_2_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdfNovember 1, 2023784 KB
27_BLA 125742 0_07 19 2021_Telecon_Advice.pdfNovember 1, 2023746 KB
32_1_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdfNovember 1, 2023890 KB
25_1_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdfNovember 1, 2023794 KB
26_2_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdfNovember 1, 2023789 KB
15_BLA 125742 0_07 02 2021_Telecon_Information Reques.pdfNovember 1, 2023819 KB
18_BLA 125742 0_07 09 2021_Telecon_Information Reques.pdfNovember 1, 2023765 KB
21_BLA 125742 0_07 15 2021_Letter_Filing Notification.pdfNovember 1, 2023722 KB
9_IND_19736_491_29 Sep 2021_DEBORAH_DEBORAH__RO_ The Summary Monthly Safety Report has been reviewed. No furthe.pdfNovember 1, 2023716 KB
10_BLA 125742 11_12 22 2021_Memo_Committee Memo_CMC.pdfNovember 1, 2023757 KB
8_1_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
8_IND_19736_453_26 Aug 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023717 KB
6_IND_19736_366_24 Jun 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023717 KB
7_IND_19736_409_26 Jul 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023718 KB
4_IND_19736_289_27 Apr 2021_DEBORAH_DEBORAH__RC_.pdfNovember 1, 2023717 KB
5_IND_19736_335_19 May 2021_DEBORAH_DEBORAH__RC_.pdfNovember 1, 2023716 KB
2_IND_19736_214_03 Mar 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023698 KB
3_BLA 125742 0_05 20 2021_Telecon_Information Reques.pdfNovember 1, 2023747 KB
3_IND_19736_243_19 Mar 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023696 KB
1_BLA 125742 0_05 13 2021_Letter_Acknowledgement Let.pdfNovember 1, 2023713 KB
1_IND_19736_185_23 Feb 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023697 KB
60_BLA 125742 0_08 11 2021_Telecon_Information Reques.pdfNovember 1, 2023764 KB
61_BLA 125742 0_08 11 2021_Telecon_Other.pdfNovember 1, 2023719 KB
55_BLA 125742 0_08 09 2021_Telecon_Advice.pdfNovember 1, 20232 MB
58_2_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdfNovember 1, 2023755 KB
53_2_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdfNovember 1, 2023765 KB
54_BLA 125742 0_08 09 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
51_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Memo COMIRNATY.pdfNovember 1, 2023279 KB
52_1_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
49_BLA 125742 0_08 06 2021_Letter_UNII Code Notificat.pdfNovember 1, 2023766 KB
019736_S70_M5_vr mqr 10211 10212 dlq.pdfOctober 1, 2023663 KB
125742_S5_M3_guidelines travel red zone belgium.pdfOctober 1, 2023643 KB
125742_S5_M3_requirements travel belgium.pdfOctober 1, 2023635 KB
019736_S157_M1_cover.pdfOctober 1, 2023668 KB
019736_S387_M5_c4591012 interim sponsor signature.pdfOctober 1, 2023664 KB
19736_S0289_M1_cover.pdfOctober 1, 2023687 KB
019736_S387_M5_c4591008 interim excluded subjects.pdfOctober 1, 2023684 KB
19736_S0369_M1_cover.pdfOctober 1, 2023704 KB
019736_S70_M1_cover.pdfOctober 1, 2023689 KB
19736_S0185_M1_cover.pdfOctober 1, 2023687 KB
19736_S0214_M1_cover.pdfOctober 1, 2023716 KB
019736_S70_M5_vr mqr 10211 10212 pq.pdfOctober 1, 2023708 KB
19736_S0243_M1_cover.pdfOctober 1, 2023733 KB
3_PM_S89_BLA 125742 5_09 21 2021_Telecon_Other.pdfOctober 1, 2023724 KB
19736_S0408_M1_cover.pdfOctober 1, 2023736 KB
19736_S0335_M1_cover.pdfOctober 1, 2023735 KB
19736_S0453_M1_cover.pdfOctober 1, 2023739 KB
19736_S0366_M1_cover.pdfOctober 1, 2023736 KB
125742_S2_M5_5.4_who 2005.pdfOctober 1, 2023747 KB
19736_S0491_M1_cover.pdfOctober 1, 2023742 KB
125742_2_BLA 125742 0_05 18 2021_Telecon_Information Reques.pdfOctober 1, 2023742 KB
019736_S414_M1_cover.pdfOctober 1, 2023753 KB
125742_S2_M5_5.4_who 2019.pdfOctober 1, 2023747 KB
019736_S488_M1_cover.pdfOctober 1, 2023756 KB
019736_S222_M1_cover.pdfOctober 1, 2023754 KB
5_PM_S102_1_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdfOctober 1, 2023782 KB
019736_S444_M5_c4591007 p2 3 older child assent lower dose eval.pdfOctober 1, 2023773 KB
019736_S196_M1_cover.pdfOctober 1, 2023759 KB
019736_S444_M5_c4591007 p1 older children assent lower dose eval icd.pdfOctober 1, 2023786 KB
6_PM_S102_2_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdfOctober 1, 2023783 KB
019736_S387_M5_c4591008 interim protocol deviations.pdfOctober 1, 2023633 KB
125742_S2_M1_356h.pdfOctober 1, 2023813 KB
7_PM_S102_BLA 125742 8_09 29 2021_Letter_Waiver Request.pdfOctober 1, 2023830 KB
19736_S0185_M1_1571.pdfOctober 1, 2023827 KB
019736_S387_M5_c4591008 interim sponsor signature.pdfOctober 1, 2023824 KB
019736_S488_M5_c4591007 p2 3 older children assent troponin icd.pdfOctober 1, 2023837 KB
11_PM_S136_BLA 125742 31_10 30 2021_Memo_Final Review Memo.pdfOctober 1, 2023835 KB
019736_S488_M5_c4591007 p2 3 parent icd pbo controlled selected dose.pdfOctober 1, 2023880 KB
019736_S222_M5_c4591020 informed consent form.pdfOctober 1, 2023867 KB
019736_S444_M5_c4591007 p2 3 adult participant icd lower dose eval.pdfOctober 1, 2023966 KB
9_PM_S105_BLA 125742 9_09 20 2021_Telecon_Advice.pdfOctober 1, 2023941 KB
4_PM_S89_BLA 125742 5_09 22 2021_Telecon_Advice.pdfOctober 1, 2023983 KB
019736_S444_M5_c4591007 p1 adult participant icd lower dose eval.pdfOctober 1, 2023974 KB
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019736_S444_M5_c4591007 p2 3 parent icd lower dose eval.pdfOctober 1, 2023988 KB
1_PM_S85_BLA 125742 4_09 30 2021_Telecon_Advice.pdfOctober 1, 20231,014 KB
019736_S488_M5_c4591007 p2 3 younger children assent troponin icd.pdfOctober 1, 20231,013 KB
019736_S70_M5_vr sop lc 11120.pdfOctober 1, 20231,020 KB
8_PM_S102_BLA 125742 8_09 29 2021_Telecon_Other.pdfOctober 1, 20231,016 KB
2_PM_S89_BLA 12572 5_09 10 2021_Telecon_Advice.pdfOctober 1, 20231 MB
019736_S444_M5_c4591007 p2 3 parent icd pbo controlled selected dose.pdfOctober 1, 20231 MB
019736_S488_M5_c4591007 p2 3 parent troponin icd.pdfOctober 1, 20231 MB
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019736_S268_M5_wi255886 sap.pdfOctober 1, 20231 MB
019736_S268_M5_wi255886 protocol.pdfOctober 1, 20231 MB
019736_S387_M5_c4591008 interim withdrawn subjects.pdfOctober 1, 20231 MB
019736_S387_M5_c4591008 interim unplanned hospitalization.pdfOctober 1, 20231 MB
019736_S196_M5_c4591008 protocol.pdfOctober 1, 20231 MB
019736_S70_M5_vr mqr 10214 att01 shi sop 10011.pdfOctober 1, 20231 MB
019736_S387_M5_c4591008 interim sample icd.pdfOctober 1, 20231 MB
019736_S31_M1_response ir 06jul2020 c4591001.pdfOctober 1, 20231 MB
019736_S70_M5_vr tm 10293.pdfOctober 1, 20232 MB
019736_S444_M5_c4591007 p2 3 younger child assent lower dose eval.pdfOctober 1, 20231 MB
125742_S1_M5_5351_c4591001 interim mth6 investigators.pdfOctober 1, 20232 MB
125742_S1_M5_5351_c4591001 fa interim investigators.pdfOctober 1, 20232 MB
019736_S387_M5_c4591008 interim non hospitalization.pdfOctober 1, 20232 MB
019736_S70_M5_vr tm 10294.pdfOctober 1, 20232 MB
125742_S75_M1_356h.pdfOctober 1, 20232 MB
019736_S444_M5_c4591007 p1 younger children assent lower dose eval icd.pdfOctober 1, 20232 MB
019736_S488_M5_c4591007 p2 3 parent icd pbo controlled selected dose track.pdfOctober 1, 20232 MB
019736_S387_M5_c4591008 interim demographics.pdfOctober 1, 20232 MB
019736_S444_M5_c4591007 p2 3 children assent cont select dose icd.pdfOctober 1, 20232 MB
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019736_S70_M5_vr mqr 10214 att03.pdfOctober 1, 20232 MB
019736_S70_M5_vr mqr 10214 att02.pdfOctober 1, 20232 MB
019736_S70_M5_vr mqr 10214 att01.pdfOctober 1, 20232 MB
019736_S444_M5_c4591007 p2 3 parent icd pbo controlled selected dose track.pdfOctober 1, 20232 MB
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019736_S444_M5_c4591007 p2 3 children assent pbo cont select dose icd track.pdfOctober 1, 20232 MB
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019736_S70_M5_vr mqr 10211 att01.pdfOctober 1, 20232 MB
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019736_S31_M5_vr mqr 10214 att01 shi sop 10011.pdfOctober 1, 20232 MB
019736_S470_M5_c4591009 protocol.pdfOctober 1, 20232 MB
019736_S488_M5_c4591007 p2 3 parent addendum icd pbo cont selected dose.pdfOctober 1, 20232 MB
019736_S222_M5_c4591020 protocol.pdfOctober 1, 20231 MB
125742_S6_M5_5351_c4591001 sequencing report.pdfOctober 1, 20232 MB
019736_S31_M1_1571.pdfOctober 1, 20232 MB
019736_S325_M1_cover.pdfOctober 1, 20232 MB
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19736_S0214_M1_1571.pdfOctober 1, 20232 MB
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019736_S70_M5_vr mqr 10214.pdfOctober 1, 20232 MB
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019736_S325_M5_c4591020 sap.pdfOctober 1, 20233 MB
019736_S31_M5_vr mqr 10214.pdfOctober 1, 20232 MB
019736_S31_M5_vr tm 10294.pdfOctober 1, 20233 MB
019736_S31_M5_vr tm 10293.pdfOctober 1, 20233 MB
019736_S70_M5_vr mqr 10211.pdfOctober 1, 20233 MB
019736_S325_M5_c4591020 sap track.pdfOctober 1, 20233 MB
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019736_S387_M5_c4591008 interim abstract.pdfOctober 1, 20233 MB
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125742_S2_M5_5.4_sedic m 2020.pdfOctober 1, 20233 MB
019736_S387_M5_c4591012 interim abstract.pdfOctober 1, 20233 MB
019736_S268_M5_c4591014 protocol.pdfOctober 1, 20233 MB
125742_S1_M5_5351_c4591001 fa interim interlab standard.pdfOctober 1, 20233 MB
125742_S2_M1_environmental analysis.pdfOctober 1, 20233 MB
019736_S268_M1_cover.pdfOctober 1, 20233 MB
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019736_S398_M1_response 30june2021 icd myo peri.pdfOctober 1, 20233 MB
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019736_S387_M5_c4591008 interim protocol.pdfOctober 1, 20234 MB
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019736_S470_M5_c4591012 protocol.pdfOctober 1, 20234 MB
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125742_S2_M5_5.4_singh dk 2020.pdfOctober 1, 20238 MB
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019736_S387_M1_cover.pdfOctober 1, 202311 MB
019736_S196_M5_c4591012 protocol.pdfOctober 1, 202313 MB
19736_S0214_M1_smsr 01jan2021 31jan2021.pdfOctober 1, 202315 MB
019736_S268_M5_wi235284 protocol.pdfOctober 1, 202316 MB
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019736_S387_M5_c4591012 interim report body.pdfOctober 1, 20235 MB
019736_S387_M5_c4591008 interim report body.pdfOctober 1, 20236 MB
019736_S387_M5_c4591008 interim compliance.pdfOctober 1, 20237 MB
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19736_S0243 smsr 01feb2021 28feb2021.pdfOctober 1, 202331 MB
19736_S0289_M1_smsr 01mar2021 31mar2021.pdfOctober 1, 202337 MB
125742_S1_M1_meeting correspondence.pdfOctober 1, 202321 MB
019736_S488_M5_c4591007 protocol amend3.pdfOctober 1, 202322 MB
125742_S1_M5_5351_bnt162 01 interim3 reports.pdfOctober 1, 202373 MB
19736_S0408_M1_smsr 01jun2021 30jun2021.pdfOctober 1, 202376 MB
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19736_S0366_M1_smsr 30apr2021 31may2021.pdfOctober 1, 202367 MB
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125742_S0136_M5_smsr-01sep2021-30sep2021.pdfOctober 1, 2023112 MB
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104B_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdfSeptember 1, 2023675 KB
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98_BLA 125742 0_08 19 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023784 KB
104_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdfSeptember 1, 2023747 KB
91_2_BLA 125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023754 KB
96_2_BLA 125742 0_08 19 2021_Telecon_Information Reques.pdfSeptember 1, 2023756 KB
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90_1_BLA 125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023810 KB
76_BLA 125742 0_08 16 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023793 KB
80_2_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfSeptember 1, 2023782 KB
82_BLA 125742 0_08 17 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023731 KB
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72_BLA 125742 0_08 13 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023753 KB
69_1_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfSeptember 1, 2023802 KB
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112_1_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdfSeptember 1, 2023747 KB
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50_BLA 125742 0_08 06 2021_Memo_Committee Memo_APLB.pdfSeptember 1, 2023771 KB
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125742_S3_M1_proprietary name.pdfApril 3, 20232 MB
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125742_S2_M5_5354_wi255886 protocol.pdfApril 3, 20231 MB
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130_BLA _125742-0_09-01-2021_Committee Memo_Labeling.pdfJanuary 3, 2023771 KB
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125742_S38_M5_c4591001-508-safety-tables.pdfJanuary 3, 2023928 KB
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125742_S39_M1_5351_c4591001-ve-tables.pdfJanuary 3, 2023695 KB
FDA-CBER-2021-5683-0652693-0652713-125742_S68_M1_lab-1448-0-6-annotated.docxJanuary 3, 2023520 KB
125742_S39_M1_lab-1448-0-3-annotated.pdfJanuary 3, 20236 MB
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FDA-CBER-2021-5683-0652735-0652755-125742_S68_M1_lab-1448-0-6-pkg-insert-track.docxJanuary 3, 2023515 KB
125742_S39_M1_lab-1448-0-3-pkg-insert-cleanJanuary 3, 20235 MB
FDA-CBER-2021-5683-0652756-0652776-125742_S70_M1_lab-1448-0-7-annotated.docxJanuary 3, 2023520 KB
FDA-CBER-2021-5683-0652777-0652797-125742_S70_M1_lab-1448-0-7-pkg-insert-clean.docxJanuary 3, 2023522 KB
125742_S39_M1_lab-1448-0-3-pkg-insert-track.pdfJanuary 3, 20235 MB
FDA-CBER-2021-5683-0652798-0652818-125742_S70_M1_lab-1448-0-7-pkg-insert-track.docxJanuary 3, 2023515 KB
FDA-CBER-2021-5683-0652819-0652838-125742_S73_M1_lab-1448-0-8-pkg-insert-clean.docxJanuary 3, 2023515 KB
125742_S41_M1_c4591001-ve-tables.pdfJanuary 3, 2023695 KB
FDA-CBER-2021-5683-0652839-0652858-125742_S73_M1_lab-1448-0-8-annotated.docxJanuary 3, 2023521 KB
FDA-CBER-2021-5683-0652859-0652878-125742_S73_M1_lab-1448-0-8-pkg-insert-track.docxJanuary 3, 2023516 KB
125742_S46_M1_carton-com25ctkz-kzooJanuary 3, 2023217 KB
FDA-CBER-2021-5683-0652879-0652898-125742_S76_M1_lab-1448-0-9-pkg-insert-clean.docxJanuary 3, 2023515 KB
FDA-CBER-2021-5683-0652899-0652919-125742_S76_M1_lab-1448-0-9-pkg-insert-track.docxJanuary 3, 2023515 KB
125742_S46_M1_carton-com25ctpus-puurs.pdfJanuary 3, 2023241 KB
FDA-CBER-2021-5683-0652920-0652940-125742_S76_M1_lab-1448-0-9-annotated.docxJanuary 3, 2023519 KB
125742_S46_M1_carton-com195lkz-kzoo.pdfJanuary 3, 2023140 KB
FDA-CBER-2021-5683-0652941-0652960-125742_S79_M1_lab-1448-1-0-pkg-insert-clean.docxJanuary 3, 2023515 KB
FDA-CBER-2021-5683-0652961-0652980-125742_S80_M1_lab-1448-1-0-pkg-insert-clean.docxJanuary 3, 2023515 KB
125742_S46_M1_carton-com195lpus-puurs.pdfJanuary 3, 2023179 KB
FDA-CBER-2021-5683-0652981-0654506-125742_S1_M5_bnt162-01-A-D-adlb.xpt.zipJanuary 3, 20233 MB
125742_S46_M1_label-comvlabkz-kzoo.pdfJanuary 3, 202349 KB
125742_S46_M1_label-comvlabp-puurs.pdfJanuary 3, 202355 KB
125742_S46_M1_sticker-comdilrm.pdfJanuary 3, 202356 KB
125742_S51_M1_lab-1448-0-4-annotatedJanuary 3, 20234 MB
125742_S51_M1_lab-1448-0-4-pkg-insert-clean.pdfJanuary 3, 20231 MB
FDA-CBER-2021-5683-0654507-0658059-125742_S1_M5_bnt162-01-S-Supp-D-suppface.xpt.zipJanuary 3, 2023612 KB
125742_S51_M1_lab-1448-0-4-pkg-insert-track.pdfJanuary 3, 20231 MB
FDA-CBER-2021-5683-0658060-0661613-125742_S1_M5_bnt162-01-S-D-face.xpt.xpt.zipJanuary 3, 20232 MB
125742_S51_M5_5351_c4591001-followup-table.pdfJanuary 3, 2023606 KB
FDA-CBER-2021-5683-0661614-0663134-125742_S1_M5_bnt162-01-S-D-lb.xpt.zipJanuary 3, 20231 MB
125742_S54_M1_carton-com25ctkz-kzoo.pdfJanuary 3, 2023218 KB
FDA-CBER-2021-5683-0663135-0671344-125742_S1_M5_c4591001-A-D-adsympt.xpt.zipJanuary 3, 20234 MB
125742_S54_M1_carton-com25ctpus-puurs.pdfJanuary 3, 2023691 KB
FDA-CBER-2021-5683-0671345-0674997-125742_S1_M5_c4591001-S-D-supplb.xpt.zipJanuary 3, 2023504 KB
FDA-CBER-2021-5683-0674998-0678267-125742_S1_M5_c4591001-S-Supp-D-suppmb.xpt.zipJanuary 3, 2023438 KB
FDA-CBER-2021-5683-0678268-0681345-125742_S1_M5_c4591001-A-D-adds.xpt.zipJanuary 3, 20237 MB
125742_S54_M1_carton-com195lkz-kzooJanuary 3, 2023135 KB
125742_S54_M1_carton-com195lpus-puurs.pdfJanuary 3, 2023179 KB
FDA-CBER-2021-5683-0681346-0688437-125742_S1_M5_c4591001-S-D-ds.xpt.zipJanuary 3, 20232 MB
125742_S58_M1_lab-1448-0-5-annotated.pdfJanuary 3, 20233 MB
FDA-CBER-2021-5683-0688438-0698919-125742_S1_M5_c4591001-S-D-vs.xpt.zipJanuary 3, 20237 MB
125742_S58_M1_lab-1448-0-5-pkg-insert-clean.pdfJanuary 3, 2023878 KB
FDA-CBER-2021-5683-0698920-0703842-125742_S1_M5_c4591001-S-D-suppae.xpt.zipJanuary 3, 2023825 KB
125742_S58_M1_lab-1448-0-5-pkg-insert-track.pdfJanuary 3, 2023879 KB
FDA-CBER-2021-5683-0703843-0708840-125742_S1_M5_c4591001-S-Supp-D-suppae.xpt.zipJanuary 3, 2023845 KB
125742_S64_M1_carton-com25ctkz-kzoo.pdfJanuary 3, 2023217 KB
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125742_S64_M1_carton-com195lkz-kzoo.pdfJanuary 3, 2023135 KB
125742_S64_M1_carton-com195lpus-puursJanuary 3, 2023178 KB
125742_S64_M1_label-comvlabkz-kzoo.pdfJanuary 3, 202349 KB
125742_S64_M1_label-comvlabp-puurs.pdfJanuary 3, 2023648 KB
125742_S64_M1_sticker-comdilrm.pdfJanuary 3, 2023180 KB
125742_S68_M1_lab-1448-0-6-annotated.pdfJanuary 3, 20233 MB
125742_S68_M1_lab-1448-0-6-pkg-insert-clean.pdfJanuary 3, 20231 MB
4_BLA_125742-0_06-03-2021_First_Committee_Meeting_Summary.pdfJanuary 3, 2023772 KB
7_BLA_125742-0_06-17-2021_Memo_Other.pdfJanuary 3, 2023682 KB
10_BLA_125742-0_06-29-2021_Filing_Meeting_Summary.pdfJanuary 3, 2023713 KB
125742_S68_M1_lab-1448-0-6-pkg-insert-track.pdfJanuary 3, 20231 MB
125742_S70_M1_lab-1448-0-7-annotated.pdfJanuary 3, 20232 MB
125742_S70_M1_lab-1448-0-7-pkg-insert-clean.pdfJanuary 3, 20231 MB
13_BLA_125742-0_07-02-2021_Committee Memo_APLB.pdfJanuary 3, 2023848 KB
125742_S70_M1_lab-1448-0-7-pkg-insert-track.pdfJanuary 3, 20231 MB
36A_BLA_125742-0_07-28-2021_Telecon_Labeling Target ClJanuary 3, 20231 MB
125742_S73_M1_lab-1448-0-8-annotated.pdfJanuary 3, 20233 MB
125742_S73_M1_lab-1448-0-8-pkg-insert-clean.pdfJanuary 3, 20231 MB
72A_BLA_125742-0_08-13-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
77_BLA_125742-0_08-17-2021_Memo_Lot Release Clearance.pdfJanuary 3, 2023805 KB
78_BLA_125742-0_08-17-2021_Memo_Other.pdfJanuary 3, 2023814 KB
82A_BLA_125742-0_08-17-2021_Telecon_Labeling via FAX_eJanuary 3, 20231 MB
125742_S73_M1_lab-1448-0-8-pkg-insert-track.pdfJanuary 3, 20231 MB
91A_2_BLA_125742-0_08-18-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
125742_S76_M1_lab-1448-0-9-annotated.pdfJanuary 3, 20231 MB
125742_S76_M1_lab-1448-0-9-pkg-insert-clean.pdfJanuary 3, 20231 MB
98A_BLA_125742-0_08-19-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
125742_S76_M1_lab-1448-0-9-pkg-insert-track.pdfJanuary 3, 20231 MB
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FDA-CBER-2021-5683-0634075-0650113-125742_S1_M5_c4591001-S-D-suppexDecember 1, 20223 MB
FDA-CBER-2021-5683-0633945-0634074-125742_S1_M5_bnt162-01-S-D-advaDecember 1, 2022169 KB
FDA-CBER-2021-5683-0633790-0633944-125742_S1_M5_bnt162-01-S-D-adcevdDecember 1, 2022133 KB
FDA-CBER-2021-5683-0623311-0633789-125742_S1_M5_c4591001-S-D-vsDecember 1, 20228 MB
FDA-CBER-2021-5683-0616659-0623310-125742_S1_M5_c4591001-S-D-svDecember 1, 20222 MB
FDA-CBER-2021-5683-0600620-0616658-125742_S1_M5_c4591001-S-D-suppecDecember 1, 20223 MB
FDA-CBER-2021-5683-0595944-0600619-125742_S1_M5_c4591001-S-D-seDecember 1, 20222 MB
FDA-CBER-2021-5683-0595465-0595943-125742_S1_M5_bnt162-01-S-D-vsDecember 1, 2022391 KB
FDA-CBER-2021-5683-0594977-0595464-125742_S1_M5_bnt162-01-S-D-suppvsDecember 1, 202286 KB
125742_S1_M4_20256434.pdf.zipNovember 1, 202220 MB
FDA-CBER-2021-5683-0539816-0593326-125742_S1_M5_c4591001-01-S-Supp-D-face.xpt.zipNovember 1, 202242 MB
FDA-CBER-2021-5683-0593327-0593481-125742_S1_M5_bnt162-01-S-D-ce.xpt.zipNovember 1, 202271 KB
FDA-CBER-2021-5683-0593482-0593595-125742_S1_M5_bnt162-01-S-D-pe.xpt.zipNovember 1, 202242 KB
FDA-CBER-2021-5683-0593596-0593620-125742_S1_M5_bnt162-01-S-D-se.xpt.zipNovember 1, 202211 KB
FDA-CBER-2021-5683-0593621-0593664-125742_S1_M5_bnt162-01-S-Supp-D-suppae.xpt.zipNovember 1, 20226 KB
FDA-CBER-2021-5683-0593665-0593743-125742_S1_M5_bnt162-01-S-Supp-D-suppcm.xpt.zipNovember 1, 202219 KB
FDA-CBER-2021-5683-0593744-0593769-125742_S1_M5_bnt162-01-S-Supp-D-suppds.xpt.zipNovember 1, 20225 KB
FDA-CBER-2021-5683-0593770-0593800-125742_S1_M5_bnt162-01-S-Supp-D-suppec.xpt.zipNovember 1, 20227 KB
FDA-CBER-2021-5683-0593801-0593831-125742_S1_M5_bnt162-01-S-Supp-D-suppex.xpt.zipNovember 1, 20226 KB
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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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FDA-CBER-2021-5683-0308157 to -0396186_125742_S1_M5_c4591001-S-D-suppface.xptAugust 1, 2022467 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
FDA CBER 2021 5683 0286267 to 0296903_125742_S1_M5_c4591001 S Supp D suppce.zip (xpt)July 1, 20221 MB
FDA CBER 2021 5683 0286072 to 0286266_125742_S1_M5_c4591001 S Supp D relrec.zip (xpt)July 1, 202254 KB
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 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_hospira diluent label.pdfJuly 1, 2022776 KB
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125742_S1_M5_5351_c4591001 fa interim sap.pdfJuly 1, 20223 MB
125742_S1_M5_5351_c4591001 fa interim narrative sensitive.pdfJuly 1, 202219 MB
125742_S1_M5_5351_c4591001 interim mth6 adverse events.zip (pdf)July 1, 202228 MB
FDA CBER 2021 5683 0208521 to 0216666_125742_S1_M5_c4591001 S Supp D suppvs.zip (xpt)June 1, 2022917 KB
FDA CBER 2021 5683 0205318 to 0208520_125742_S1_M5_c4591001 S Supp D ex.zip (xpt)June 1, 20222 MB
FDA CBER 2021 5683 0196049 to 0205317_125742_S1_M5_c4591001 S Supp D ce.zip (xpt)June 1, 20228 MB
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 0169082 to 0171523_125742_S1_M5_c4591001 S D suppdm.zip (xpt)June 1, 2022334 KB
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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
125742_S1_M5_CRF_c4591001 1081 10811194 reissue.pdfJune 1, 20222 MB
STN 125742 0 0 Section 2.5 Clinical Overview reissue.pdfJune 1, 20225 MB
125742_S1_M5_CRF_c4591001 1128 11281009 reissue.pdfJune 1, 20222 MB
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125742_S1_M5_5351_c4591001 interim mth6 sponsor signature.pdfMay 2, 202212 MB
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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-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsxMarch 1, 202223 KB
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125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdfMarch 1, 20222 MB
125742_S1_M5_c4591001-A-report-cci-rheumatic.pdfMarch 1, 2022629 KB
125742_S1_M5_c4591001-A-report-cci-renal.pdfMarch 1, 2022629 KB
125742_S1_M5_c4591001-A-report-cci-pulmonary.pdfMarch 1, 2022630 KB
125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdfMarch 1, 2022632 KB
125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdfMarch 1, 2022625 KB
125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdfMarch 1, 2022626 KB
125742_S1_M5_CRF_c4591001-1085-10851246.pdfMarch 1, 20221 MB
125742_S1_M5_CRF_c4591001-1085-10851216.pdfMarch 1, 20221 MB
125742_S1_M5_CRF_c4591001-1085-10851129.pdfMarch 1, 20222 MB
125742_S1_M5_CRF_c4591001-1085-10851116.pdfMarch 1, 20221 MB
125742_S1_M5_CRF_c4591001-1085-10851018.pdfMarch 1, 20222 MB
125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdfMarch 1, 202217 MB
125742_S1_M5_c4591001-T-S-suppl-arg.pdfMarch 1, 2022738 KB
125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdfMarch 1, 2022667 KB
125742_S1_M5_c4591001-T-S-roadmap.pdfMarch 1, 2022703 KB
125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdfMarch 1, 2022627 KB
125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdfMarch 1, 2022626 KB
125742_S1_M5_c4591001-A-report-cci-dementia.pdfMarch 1, 2022626 KB
125742_S1_M5_c4591001-A-report-cci-chf.pdfMarch 1, 2022628 KB
125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdfMarch 1, 2022632 KB
125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdfMarch 1, 2022670 KB
125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdfMarch 1, 2022629 KB
125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdfMarch 1, 2022846 KB
125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdfMarch 1, 2022607 KB
125742_S1_M5_c4591001-A-comorbidity-categories.pdfMarch 1, 2022637 KB
125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdfMarch 1, 2022620 KB
125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdfMarch 1, 2022634 KB
125742_S1_M5_c4591001-A-report-cci-mild-liver.pdfMarch 1, 2022628 KB
125742_S1_M5_c4591001-A-report-cci-mi.pdfMarch 1, 2022624 KB
125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdfMarch 1, 2022636 KB
125742_S1_M5_c4591001-A-report-cci-lymphoma.pdfMarch 1, 2022640 KB
125742_S1_M5_c4591001-A-report-cci-leukemia.pdfMarch 1, 2022631 KB
125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdfMarch 1, 2022626 KB
125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdfMarch 1, 202237 MB
125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdfMarch 1, 202213 MB
125742_S1_M5_5351_c4591001-fa-interim-protocol.pdfMarch 1, 202231 MB
125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdfMarch 1, 20225 MB
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdfMarch 1, 202212 MB
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdfMarch 1, 202216 MB
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-errata.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdfMarch 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-compliance.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdfMarch 1, 2022889 KB
125742_S1_M5_c4591001-A-bmi-12-15-scale.pdfMarch 1, 2022627 KB
125742_S1_M5_c4591001-A-adrg.pdfMarch 1, 20222 MB
125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdfMarch 1, 2022602 KB
125742_S1_M1_us-agent-authorization.pdfMarch 1, 20221 MB
125742_S1_M1_trans-of-oblig.pdfMarch 1, 2022717 KB
125742_S1_M1_ipsp-agreed-letter.pdfMarch 1, 2022658 KB
125742_S1_M1_financial-cert-bias.pdfMarch 1, 2022696 KB
125742_S1_M1_financial-cert-3454.pdfMarch 1, 20223 MB
125742_S1_M1_fast-track-designation.pdfMarch 1, 2022649 KB
125742_S1_M1_exclusivity-claim.pdfMarch 1, 2022616 KB
125742_S1_M1_debarment.pdfMarch 1, 2022656 KB
125742_S1_M1_cover.pdfMarch 1, 20221 MB
125742_S1_M1_3674.pdfMarch 1, 20225 MB
125742_S1_M1_356h.pdfMarch 1, 2022714 KB
125742_S1_M4_4223_R-20-0072.pdfMarch 1, 20225 MB
125742_S1_M4_4223_185350.pdfMarch 1, 20221 MB
125742_S1_M2_27_synopses-indiv-studies.pdfMarch 1, 20222 MB
125742_S1_M2_27_literature-references.pdfMarch 1, 20222 MB
125742_S1_M2_26_pharmkin-written-summary.pdfMarch 1, 20221 MB
125742_S1_M2_26_pharmkin-tabulated-summary.pdfMarch 1, 20221 MB
125742_S1_M2_24_nonclinical-overview.pdfMarch 1, 20222 MB
125742_S1_M2_22_introduction.pdfMarch 1, 2022670 KB
125742_S1_M1_waiver-req-designated-suffix.pdfMarch 1, 20223 MB
125742_S1_M1_userfee.pdfMarch 1, 2022628 KB
CRFs-for-site-1128.pdfJanuary 31, 202214 MB
CRFs-for-site-1096.pdfJanuary 18, 202211 MB
CRFs-for-site-1081.pdfDecember 30, 202113 MB
Supplemental-Index-12-22-21.pdfDecember 22, 20212 MB
STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdfDecember 13, 20216 MB
STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdfDecember 13, 20213 MB
STN-125742_0_0-Section-2.5-Clinical-Overview.pdfDecember 13, 20214 MB
signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdfDecember 13, 2021207 KB
CRFs-for-site-1055.pdfDecember 13, 20216 MB
BATES-FDA-CBER-2021-5683-0002379_te.xptDecember 13, 20213 KB
BATES-FDA-CBER-2021-5683-0002380_ti.xptDecember 13, 202137 KB
BATES-FDA-CBER-2021-5683-0002377_supppr.xptDecember 13, 202172 KB
BATES-FDA-CBER-2021-5683-0002378_ta.xptDecember 13, 20218 KB
BATES-FDA-CBER-2021-5683-0002376_relrec.xptDecember 13, 2021567 KB
BATES-FDA-CBER-2021-5683-0002375_addv-sas.txtDecember 13, 20215 KB
BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txtDecember 13, 20219 KB
BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdfDecember 1, 202114 MB
Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdfDecember 1, 202112 MB
BATES-93_tv.xptNovember 17, 202116 KB
5.2-tabular-listing.pdfNovember 17, 20212 MB
5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdfNovember 17, 20218 MB
BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txtNovember 17, 20219 KB
5.3.6-postmarketing-experience.pdfNovember 17, 2021984 KB
TitleDateFile SizeLink
034 – Transcript of Scheduling Conference (December 14, 2021).pdfMarch 17, 2022141 KB
Order-February-7-2022.pdfFebruary 7, 2022151 KB
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
047-PLAINTIFFS-RESPONSE-TO-PFIZER-INC.S-MOTION-FOR-LEAVE-TO-INTERVENE-FOR-A-LIMITED-PURPOSE.pdfJanuary 25, 2022293 KB
046-RESPONSE-filed-by-Food-and-Drug-Administration-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdfJanuary 25, 2022128 KB
044-PL-PHPMTS-MOL-IN-OPPOSITION-TO-DEFENDANTS-MOTION-TO-MODIFY-THE-SCHEDULING-ORDER-OF-THE-COURT.pdfJanuary 24, 2022420 KB
041-Memorandum-in-Support-filed-by-Pfizer-Inc.-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdfJanuary 21, 20221,014 KB
038-Appendix-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order.pdfJanuary 18, 20221 MB
037-Brief-Memorandum-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order-1.pdfJanuary 18, 2022247 KB
ORDER_2022_01_06.pdfJanuary 6, 2022169 KB
032-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-31-Reply.pdfDecember 13, 202124 MB
031-REPLY-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-22-Brief-Memorandum-in-Support-of-Motion.pdfDecember 13, 2021175 KB
030-FDAs-Appendix-in-Support-of-Brief.pdfDecember 13, 20211 MB
029-FDAs-Reply-re-Brief-in-Support-of-Motion.pdfDecember 13, 2021280 KB
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
026-Brief-Memorandum-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-21-Order-Setting-DeadlineHearing.pdfDecember 7, 2021239 KB
023-FDA-Appendix-in-Support-1.pdfDecember 6, 20219 MB
022-FDA-Brief-in-Advance-of-Scheduling-Conference.pdfDecember 6, 2021273 KB
111521-Second-Joint-Status-Report.pdfNovember 15, 2021382 KB
091621-Complaint.pdfSeptember 16, 20211 MB

Pfizer’s Documents – Full Productions

TitleDateFile SizeLink
pd-production-110123.zipNovember 1, 2023337 MB
pd-production-100123.zipOctober 1, 20231.3 GB
pd-production-090123.zipSeptember 1, 2023248MB
pd-production-080123.zipAugust 1, 2023804MB
pd production 070323 4.zipJuly 3, 202350 MB
pd production 070323 1.zipJuly 3, 2023101 MB
pd production 070323 2.zipJuly 3, 2023107 MB
pd production070323 3.zipJuly 3, 2023103 MB
pd production 060123 1.zipJune 1, 2023110 MB
pd production 060123 2.zipJune 1, 2023110 MB
pd production 060123 3.zipJune 1, 202397 MB
pd-production-050123-1.zipMay 1, 2023183 MB
pd-production-050123-2.zipMay 1, 2023165 MB
pd production 040323.zipApril 3, 2023196 MB
pd production 030123.zipMarch 1, 202345 MB
pd-production-020123.zipFebruary 1, 2023126 MB
pd-production-010323-1.zipJanuary 3, 2023124 MB
pd-production-010323-2.zipJanuary 3, 202330 MB
pd-production-120122.zipDecember 1, 202220 MB
pd-production-110122.zipNovember 1, 202271 MB
pd-production-100322.zipOctober 3, 202255 MB
pd-production-090122.zipSeptember 1, 202211 MB
pd-production-080122.zipAugust 1, 202248 MB
pd-production-070122.zipJuly 1, 2022199 MB
pd-production-060122.zipJune 1, 2022157 MB
pd-production-050222.zipMay 2, 2022396 MB
pd-production-040122.zipApril 1, 2022128 MB
pd-production-032422.zipMarch 24, 20222 MB
pd-production-030122.zipMarch 1, 2022195 MB
pd-production-013122.zipJanuary 31, 202214 MB
pd-production-011822.zipJanuary 18, 202211 MB
pd-production-123021.zipDecember 30, 202113 MB
pd-production-122221.zipDecember 22, 20212 MB
pd-production-121321.zipDecember 13, 202121 MB
pd-production-120121.zipDecember 1, 202126 MB
pd-production-111721.zipNovember 17, 202111 MB

Court Documents – Full Productions

TitleDateFile SizeLink
cd-production-031622.zipMarch 17, 2022101 KB
cd-production-020722.zipFebruary 7, 2022151 KB
cd-production-020222.zipFebruary 2, 2022125 KB
cd-production-012522.zipJanuary 25, 2022422 KB
cd-production-012422.zipJanuary 24, 2022420 KB
cd-production-012122.zipJanuary 21, 20221,014 KB
cd-production-011822.zipJanuary 18, 20221 MB
cd-production-010622.zipJanuary 6, 2022170 KB
cd-production-121321.zipDecember 13, 202126 MB
cd-production-120721.zipDecember 7, 202117 MB
cd-production-120621.zipDecember 6, 20219 MB
cd-production-111521.zipNovember 15, 2021382 KB
cd-production-091621.zipSeptember 16, 20211 MB