Public Health and Medical Professionals for Transparency Documents

Pfizer 12-15 Documents

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File NameTypeDate ProducedSizeLinkhf:file_type
FDA CBER 2022 5812 0502745 0502746_125742 45_04 22 2022_Memo_Committee Memo_Consu_AxptJanuary 2, 2024113 KBxpt
FDA CBER 2022 5812 0502742 0502744_125742 45_02 07 2022_Memo_Filing Checklist_RPM_A_5docxJanuary 2, 202449 KBdocx
FDA CBER 2022 5812 0502740 0502741_125742 45_02 07 2022_Memo_Filing Checklist_RPM_A_4xlsxJanuary 2, 202415 KBxlsx
FDA CBER 2022 5812 0502739_125742 45_02 07 2022_Memo_Filing Checklist_RPM_A_3xlsxJanuary 2, 202411 KBxlsx
FDA CBER 2022 5812 0502549 0502738_125742 45_02 07 2022_Memo_Filing Checklist_RPM_A_2xlsxJanuary 2, 2024330 KBxlsx
FDA CBER 2022 5812 0500510 0502548_125742 45_02 07 2022_Memo_Filing Checklist_RPM_A_1xlsxJanuary 2, 20243 MBxlsx
FDA CBER 2022 5812 0502747 0502936 _125742 45_04 22 2022_Memo_Committee Memo_Consu_BxlsxJanuary 2, 2024330 KBxlsx
FDA CBER 2022 5812 0490142 0490786_125742 45_S211_M5_c4591001 S_6mth D_svxptJanuary 2, 20243 MBxpt
FDA CBER 2022 5812 0488675 0490141_125742 45_S211_M5_c4591001 S_6mth D_suppvsxptJanuary 2, 20247 MBxpt
FDA CBER 2022 5812 0488566 0488674_125742 45_S211_M5_c4591001 S_6mth D_suppmhxptJanuary 2, 2024495 KBxpt
FDA CBER 2022 5812 0490787 0491860_125742 45_S211_M5_c4591001 S_6mth D_vszipJanuary 2, 20241,003 KBzip
FDA CBER 2022 5812 0487987 0488080_125742 45_S211_M5_c4591001 S_6mth D_supplbxptJanuary 2, 2024359 KBxpt
FDA CBER 2022 5812 0487795 0487986_125742 45_S211_M5_c4591001 S_6mth D_suppisxptJanuary 2, 2024565 KBxpt
FDA CBER 2022 5812 0487646 0487794_125742 45_S211_M5_c4591001 S_6mth D_supphoxptJanuary 2, 2024673 KBxpt
FDA CBER 2022 5812 0486832 0487645_125742 45_S211_M5_c4591001 S_6mth D_suppecxptJanuary 2, 20246 MBxpt
FDA CBER 2022 5812 0486499 0486831_125742 45_S211_M5_c4591001 S_6mth D_suppdvxptJanuary 2, 20242 MBxpt
FDA CBER 2022 5812 0486335 0486498_125742 45_S211_M5_c4591001 S_6mth D_suppdsxptJanuary 2, 2024556 KBxpt
FDA CBER 2022 5812 0486217 0486334_125742 45_S211_M5_c4591001 S_6mth D_suppdmxptJanuary 2, 2024683 KBxpt
FDA CBER 2022 5812 0486036 0486216_125742 45_S211_M5_c4591001 S_6mth D_suppaexptJanuary 2, 20241 MBxpt
FDA CBER 2022 5812 0488081 0488565_125742 45_S211_M5_c4591001 S_6mth D_suppmbxptJanuary 2, 20242 MBxpt
FDA CBER 2022 5812 0485684 0485792_125742 45_S211_M5_c4591001 S_6mth D_mhxptJanuary 2, 20243 MBxpt
FDA CBER 2022 5812 0485197 0485683_125742 45_S211_M5_c4591001 S_6mth D_mbxptJanuary 2, 20246 MBxpt
FDA CBER 2022 5812 0485104 0485196_125742 45_S211_M5_c4591001 S_6mth D_lbxptJanuary 2, 20241 MBxpt
FDA CBER 2022 5812 0484912 0485103_125742 45_S211_M5_c4591001 S_6mth D_isxptJanuary 2, 20242 MBxpt
FDA CBER 2022 5812 0484785 0484911_125742 45_S211_M5_c4591001 S_6mth D_hoxptJanuary 2, 20241 MBxpt
FDA CBER 2022 5812 0484778 0484784_125742 45_S211_M5_c4591001 S_6mth D_fahoxptJanuary 2, 2024127 KBxpt
FDA CBER 2022 5812 0485793 0486035_125742 45_S211_M5_c4591001 S_6mth D_sexptJanuary 2, 20241 MBxpt
FDA CBER 2022 5812 0484454 0484615_125742 45_S211_M5_c4591001 S_6mth D_ecxptJanuary 2, 20242 MBxpt
FDA CBER 2022 5812 0484371 0484453_125742 45_S211_M5_c4591001 S_6mth D_dvxptJanuary 2, 20241 MBxpt
FDA CBER 2022 5812 0483974 0484370_125742 45_S211_M5_c4591001 S_6mth D_dsxptJanuary 2, 20244 MBxpt
FDA CBER 2022 5812 0483918 0483973_125742 45_S211_M5_c4591001 S_6mth D_dmxptJanuary 2, 2024723 KBxpt
FDA CBER 2022 5812 0483653 0483917_125742 45_S211_M5_c4591001 S_6mth D_coxptJanuary 2, 20243 MBxpt
FDA CBER 2022 5812 0484616 0484777_125742 45_S211_M5_c4591001 S_6mth D_exxptJanuary 2, 20242 MBxpt
FDA CBER 2022 5812 0482252 0482289_125742 45_S211_M5_c4591001 S_6mth D_aexptJanuary 2, 20241 MBxpt
FDA CBER 2022 5812 0479462 0482251_125742 45_S211_M5_c4591001 S_1mth D_suppisxptJanuary 2, 20248 MBxpt
FDA CBER 2022 5812 0479457 0479461_125742 45_S211_M5_c4591001 S_1mth D_suppiexptJanuary 2, 202459 KBxpt
FDA CBER 2022 5812 0477585 0479456_125742 45_S211_M5_c4591001 S_1mth D_supphoxptJanuary 2, 20248 MBxpt
FDA CBER 2022 5812 0477186 0477584_125742 45_S211_M5_c4591001 S_1mth D_suppcmxptJanuary 2, 20243 MBxpt
FDA CBER 2022 5812 0476766 0477185_125742 45_S211_M5_c4591001 S_1mth D_pexptJanuary 2, 20249 MBxpt
FDA CBER 2022 5812 0482290 0483652_125742 45_S211_M5_c4591001 S_6mth D_cezipJanuary 2, 2024982 KBzip
FDA CBER 2022 5812 0469833 0471840_125742 45_S211_M5_c4591001 S_1mth D_lbzipJanuary 2, 20242 MBzip
FDA CBER 2022 5812 0467043 0469832_125742 45_S211_M5_c4591001 S_1mth D_iszipJanuary 2, 20241 MBzip
FDA CBER 2022 5812 0465437 0467042_125742 45_S211_M5_c4591001 S_1mth D_hozipJanuary 2, 2024735 KBzip
FDA CBER 2022 5812 0465342 0465436_125742 45_S211_M5_c4591001 S_1mth D_fahoxptJanuary 2, 20242 MBxpt
FDA CBER 2022 5812 0464415 0465341_125742 45_S211_M5_c4591001 S_1mth D_dvzipJanuary 2, 2024587 KBzip
FDA CBER 2022 5812 0463213 0464414_125742 45_S211_M5_c4591001 S_1mth D_dmzipJanuary 2, 20241 MBzip
FDA CBER 2022 5812 0459488 0463212_125742 45_S211_M5_c4591001 S_1mth D_cozipJanuary 2, 20241 MBzip
FDA CBER 2022 5812 0459289 0459487_125742 45_S211_M5_c4591001 S_1mth D_cmxptJanuary 2, 20244 MBxpt
FDA CBER 2022 5812 0458302 0459288_125742 45_S211_M5_c4591001 S_1mth D_aezipJanuary 2, 20242 MBzip
FDA CBER 2022 5812 0458301_125742 45_S211_M5_c4591001 A_6mth D_adxbxptJanuary 2, 202425 KBxpt
FDA CBER 2022 5812 0457432 0458300_125742 45_S211_M5_c4591001 A_6mth D_adsymptzipJanuary 2, 2024611 KBzip
FDA CBER 2022 5812 0457376 0457431_125742 45_S211_M5_c4591001 A_6mth D_adslxptJanuary 2, 20246 MBxpt
FDA CBER 2022 5812 0457267 0457375_125742 45_S211_M5_c4591001 A_6mth D_admhxptJanuary 2, 20247 MBxpt
FDA CBER 2022 5812 0457184 0457266_125742 45_S211_M5_c4591001 A_6mth D_addvxptJanuary 2, 20243 MBxpt
FDA CBER 2022 5812 0457020 0457183_125742 45_S211_M5_c4591001 A_6mth D_addsxptJanuary 2, 20248 MBxpt
FDA CBER 2022 5812 0457010 0457019_125742 45_S211_M5_c4591001 A_6mth D_adcmxptJanuary 2, 2024646 KBxpt
FDA CBER 2022 5812 0471841 0476765_125742 45_S211_M5_c4591001 S_1mth D_mhzipJanuary 2, 202411 MBzip
FDA CBER 2022 5812 0453944 0453969_125742 45_S211_M5_c4591001 A_6mth D_adaexptJanuary 2, 20242 MBxpt
FDA CBER 2022 5812 0451085 0453943_125742 45_S211_M5_c4591001 A_1mth D_advazipJanuary 2, 20248 MBzip
FDA CBER 2022 5812 0449883 0451084_125742 45_S211_M5_c4591001 A_1mth D_adslzipJanuary 2, 20247 MBzip
FDA CBER 2022 5812 0444958 0449882_125742 45_S211_M5_c4591001 A_1mth D_admhzipJanuary 2, 202429 MBzip
FDA CBER 2022 5812 0444460 0444957_125742 45_S211_M5_c4591001 A_1mth D_adcmzipJanuary 2, 20242 MBzip
FDA CBER 2022 5812 0443646 0444459_125742 45_S211_M5_c4591001 S_6mth D_suppexxptJanuary 2, 20246 MBxpt
FDA CBER 2022 5812 0453970 0457009_125742 45_S211_M5_c4591001 A_6mth D_adc19efzipJanuary 2, 20242 MBzip
FDA CBER 2022 5812 0435945 0442718_125742 45_S211_M5_c4591001 A_1mth D_adcevdzipJanuary 2, 20248 MBzip
FDA CBER 2022 5812 0435013 0435944_125742 45_S211_M5_c4591001 A_1mth D_adaezipJanuary 2, 20246 MBzip
FDA CBER 2022 5812 0442719 0443645_125742 45_S211_M5_c4591001 A_1mth D_addvzipJanuary 2, 20242 MBzip
Courtesy Copy_BLA 125742 45_07 08 2022_Letter_ApprovalpdfJanuary 2, 2024136 KBpdf
Courtesy Copy_BLA 125742 45_04 11 2022_Memo_Committee Memo Statistical ReviewpdfJanuary 2, 2024416 KBpdf
125742 45_S252_M5_c4591001 S_roadmappdfJanuary 2, 2024659 KBpdf
125742 45_S252_M5_c4591001 S_1mth suppl reacto tlfpdfJanuary 2, 20243 MBpdf
125742 45_S252_M5_c4591001 S_1mth suppl reacto tables trackpdfJanuary 2, 20246 MBpdf
125742 45_S252_M5_c4591001 S_1mth suppl argpdfJanuary 2, 2024648 KBpdf
125742 45_S211_M5_c4591001 S_6mth csdrgpdfJanuary 2, 20241 MBpdf
125742 45_S211_M5_c4591001 S_6mth acrfpdfJanuary 2, 20243 MBpdf
125742 45_S211_M5_c4591001 S_1mth csdrgpdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 S_1mth acrfpdfJanuary 2, 20243 MBpdf
125742 45_S211_M5_c4591001 interim ado narrative sensitivepdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 narrativepdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 investigatorspdfJanuary 2, 20241 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 compliancepdfJanuary 2, 20244 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 audit certificatespdfJanuary 2, 20241 MBpdf
125742 45_S211_M5_c4591001 interim ado investigatorspdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 interim ado compliancepdfJanuary 2, 20247 MBpdf
125742 45_S211_M5_c4591001 A_6mth adrgpdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 A_1mth supplementaldatadefinitionspdfJanuary 2, 20242 MBpdf
Courtesy Copy_BLA 125742 45_07 08 2022_Memo_Committee Memo Clinical ReviewpdfJanuary 2, 2024842 KBpdf
125742 45_S211_M5_c4591001 1223 12231273pdfJanuary 2, 20243 MBpdf
125742 45_S211_M5_c4591001 1156 11561357pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1150 11501294pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1150 11501210pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1147 11471327pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1147 11471281pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1139 11391246pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1131 11311301pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1091 10911447pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1039 10391285pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1016 10161327pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1009 10091382pdfJanuary 2, 20243 MBpdf
125742 45_S211_M5_c4591001 1009 10091294pdfJanuary 2, 20243 MBpdf
125742 45_S211_M5_c4591001 1009 10091221pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1007 10071581pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1007 10071499pdfJanuary 2, 20242 MBpdf
125742 45_S211_M5_c4591001 1005 10051449pdfJanuary 2, 20241 MBpdf
125742 45_S211_M5_c4591001 A_1mth adrgpdfJanuary 2, 20241 MBpdf
125742 45_S211_M5_c4591001 1270 12701237pdfJanuary 2, 20245 MBpdf
125742 45_07 08 2022_Memo_OtherpdfJanuary 2, 2024665 KBpdf
125742 45_07 05 2022_Telecon_Labeling via FAXpdfJanuary 2, 2024713 KBpdf
125742 45_07 01 2022_Memo_Compliance Check AccpdfJanuary 2, 2024772 KBpdf
125742 45_06 29 2022_Telecon_Labeling via FAXpdfJanuary 2, 2024733 KBpdf
125742 45_06 27 2022_Memo_Request For ComplianpdfJanuary 2, 2024765 KBpdf
125742 45_06 13 2022_Telecon_Covid 19 DelaypdfJanuary 2, 2024736 KBpdf
125742 45_06 10 2022_Memo_Committee Memo_BIMOpdfJanuary 2, 2024742 KBpdf
125742 45_05 19 2022_Memo_Committee Memo_PostmpdfJanuary 2, 2024735 KBpdf
125742 45_05 13 2022_Memo_Lot Release ClearancpdfJanuary 2, 2024785 KBpdf
125742 45_05 11 2022_Memo_Lot Release ClearancpdfJanuary 2, 2024754 KBpdf
125742 45_05 11 2022_Memo_Committee Memo_APLBpdfJanuary 2, 2024689 KBpdf
125742 45_05 10 2022_Telecon_Labeling via FAXpdfJanuary 2, 20241 MBpdf
125742 45_05 06 2022_Memo_ReviewpdfJanuary 2, 2024962 KBpdf
125742 45_05 06 2022_Meeting Summary_CommitteepdfJanuary 2, 2024766 KBpdf
125742 45_05 04 2022_Telecon_Information RequepdfJanuary 2, 2024730 KBpdf
125742 45_05 02 2022_Memo_Committee Memo_CMCpdfJanuary 2, 2024800 KBpdf
125742 45_04 26 2022_Telecon_Information RequepdfJanuary 2, 2024667 KBpdf
125742 45_04 22 2022_Telecon_Information RequepdfJanuary 2, 2024721 KBpdf
125742 45_04 22 2022_Memo_Committee Memo_ConsupdfJanuary 2, 2024800 KBpdf
125742 45_04 20 2022_Telecon_Labeling Target CpdfJanuary 2, 20242 MBpdf
125742 45_04 20 2022_Telecon_Information RequepdfJanuary 2, 2024730 KBpdf
125742 45_04 08 2022_Telecon_Information RequepdfJanuary 2, 2024700 KBpdf
125742 45_04 07 2022_Meeting Summary_Mid CyclepdfJanuary 2, 2024722 KBpdf
125742 45_03 14 2022_Telecon_Information RequepdfJanuary 2, 2024719 KBpdf
125742 45_03 08 2022_Telecon_OtherpdfJanuary 2, 2024722 KBpdf
125742 45_03 07 2022_Telecon_Information RequepdfJanuary 2, 2024721 KBpdf
125742 45_03 02 2022_Meeting Summary_CommitteepdfJanuary 2, 2024674 KBpdf
125742 45_02 23 2022_Telecon_Information RequepdfJanuary 2, 2024719 KBpdf
125742 45_02 09 2022_Letter_Filing NotificatiopdfJanuary 2, 2024695 KBpdf
125742 45_02 07 2022_Memo_Filing Checklist_RPM_ApdfJanuary 2, 2024778 KBpdf
125742 45_02 07 2022_Memo_Filing Checklist_RPMpdfJanuary 2, 2024795 KBpdf
125742 45_01 31 2022_Meeting Summary_Filing MepdfJanuary 2, 2024710 KBpdf
125742 45_01 25 2022_Telecon_Information RequepdfJanuary 2, 2024720 KBpdf
125742 45_01 19 2022_Telecon_Information RequepdfJanuary 2, 2024729 KBpdf
125742 45_01 06 2022_Meeting Summary_First CompdfJanuary 2, 2024735 KBpdf
125742 45_01 05 2022_Letter_Acknowledgement LepdfJanuary 2, 2024684 KBpdf
125742 45_S211_M1_financial cert biaspdfJanuary 2, 2024701 KBpdf
125742 45_S211_M1_financial cert 3455pdfJanuary 2, 2024695 KBpdf
125742 45_S211_M1_financial cert 3454pdfJanuary 2, 2024747 KBpdf
125742 45_08 02 2022_Memo_Committee Memo_ReviepdfJanuary 2, 2024680 KBpdf
125742 45_08 02 2022_Memo_Committee Memo_LabelpdfJanuary 2, 2024688 KBpdf
125742 45_S252_M5_summary differences csr vs update.pdfpdfDecember 4, 2023659 KBpdf
125742 45_S267_M1_response 23feb2022.pdfpdfDecember 4, 2023731 KBpdf
125742 45_S267_M5_sum post auth ae report exclude us.pdfpdfDecember 4, 2023934 KBpdf
125742 45_S267_M5_sum post auth ae report us.pdfpdfDecember 4, 2023725 KBpdf
125742 45_S271_M1_appendix 1 immunobridging data c4591001.pdfpdfDecember 4, 20231 MBpdf
125742 45_S271_M1_appendix 2 track changes immunobridging data c4591001.pdfpdfDecember 4, 2023741 KBpdf
125742 45_S271_M1_response 07mar2022.pdfpdfDecember 4, 2023749 KBpdf
125742 45_S273_M1_req comments advice sbla.pdfpdfDecember 4, 20232 MBpdf
125742 45_S328_M1_lab 1490 1 2 pkg insert clean.pdfpdfDecember 4, 20231 MBpdf
125742 45_S312_M1_lab 1448 2 1 annotated.pdfpdfDecember 4, 20233 MBpdf
125742 45_S312_M1_lab 1448 2 1 pkg insert clean.pdfpdfDecember 4, 20231 MBpdf
125742 45_S314_M1_pharmacovigilance plan.pdfpdfDecember 4, 20233 MBpdf
125742 45_S314_M1_pharmacovigilance plan track.pdfpdfDecember 4, 20232 MBpdf
125742 45_S316_M1_response 22april2022.pdfpdfDecember 4, 2023705 KBpdf
125742 45_S321_M1_response 04may2022.pdfpdfDecember 4, 2023722 KBpdf
125742 45_S328_M1_lab 1448 2 2 annotated.pdfpdfDecember 4, 20232 MBpdf
125742 45_S328_M1_lab 1448 2 2 pkg insert clean.pdfpdfDecember 4, 20232 MBpdf
125742 45_S328_M1_lab 1490 1 2 annotated.pdfpdfDecember 4, 20232 MBpdf
FDA CBER 2022 5812 0236387 0236415_125742 45_S211_M1_comirnaty.xmlxmlDecember 4, 2023181 KBxml
FDA CBER 2022 5812 0236417_125742 45_S211_M1_comirnaty 02.jpgjpgDecember 4, 202317 KBjpg
FDA CBER 2022 5812 0236418_125742 45_S211_M1_comirnaty 03.jpgjpgDecember 4, 202327 KBjpg
FDA CBER 2022 5812 0236419_125742 45_S211_M1_comirnaty 04.jpgjpgDecember 4, 202332 KBjpg
FDA CBER 2022 5812 0236420_125742 45_S211_M1_comirnaty 05.jpgjpgDecember 4, 202318 KBjpg
FDA CBER 2022 5812 0236421_125742 45_S211_M1_comirnaty 06.jpgjpgDecember 4, 202322 KBjpg
FDA CBER 2022 5812 0236422_125742 45_S211_M1_comirnaty 07.jpgjpgDecember 4, 202321 KBjpg
FDA CBER 2022 5812 0236423_125742 45_S211_M1_comirnaty 08.jpgjpgDecember 4, 20235 KBjpg
FDA CBER 2022 5812 0236424_125742 45_S211_M1_comirnaty 09.jpgjpgDecember 4, 2023109 KBjpg
FDA CBER 2022 5812 0236425_125742 45_S211_M1_comirnaty 10.jpgjpgDecember 4, 2023458 KBjpg
FDA CBER 2022 5812 0236426_125742 45_S211_M1_comirnaty 11.jpgjpgDecember 4, 2023798 KBjpg
FDA CBER 2022 5812 0236416_125742 45_S211_M1_comirnaty 01.jpgjpgDecember 4, 202323 KBjpg
FDA CBER 2022 5812 0236613 0236639_125742 45_S328_M1_lab 1448 2 2 pkg insert track.docxdocxDecember 4, 20231 MBdocx
FDA CBER 2022 5812 0236640 0236663_125742 45_S328_M1_lab 1490 1 2 pkg insert clean.docxdocxDecember 4, 2023660 KBdocx
FDA CBER 2022 5812 0236664 0236688_125742 45_S328_M1_lab 1490 1 2 pkg insert track.docxdocxDecember 4, 2023667 KBdocx
FDA CBER 2022 5812 0236689 0236715_125742 45_S364_M1_lab 1448 2 3 annotated.docdocDecember 4, 20231 MBdoc
FDA CBER 2022 5812 0236716 0236742_125742 45_S364_M1_lab 1448 2 3 pkg insert track.docxdocxDecember 4, 20231 MBdocx
FDA CBER 2022 5812 0236743 0236766_125742 45_S364_M1_lab 1490 1 3 annotated.docdocDecember 4, 2023889 KBdoc
FDA CBER 2022 5812 0236767 0236790_125742 45_S364_M1_lab 1490 1 3 pkg insert track.docxdocxDecember 4, 2023659 KBdocx
FDA CBER 2022 5812 0236427 0236451_125742 45_S211_M1_lab 1448 1 1b annotated.docxdocxDecember 4, 2023558 KBdocx
FDA CBER 2022 5812 0236452 0236476_125742 45_S211_M1_lab 1448 1 1b pkg insert clean.docxdocxDecember 4, 2023537 KBdocx
FDA CBER 2022 5812 0236477 0236501_125742 45_S211_M1_lab 1448 1 1b pkg insert track.docxdocxDecember 4, 2023545 KBdocx
FDA CBER 2022 5812 0236502 0236531_125742 45_S211_M5_c4591001 508 tables 12 15.docxdocxDecember 4, 202399 KBdocx
FDA CBER 2022 5812 0236532 0236558_125742 45_S312_M1_lab 1448 2 1 pkg insert clean.docxdocxDecember 4, 20231 MBdocx
FDA CBER 2022 5812 0236559 0236585_125742 45_S312_M1_lab 1448 2 1 pkg insert track.docxdocxDecember 4, 20231 MBdocx
FDA CBER 2022 5812 0236586 0236612_125742 45_S328_M1_lab 1448 2 2 pkg insert clean.docxdocxDecember 4, 20231 MBdocx
IND 019736_S434_IND 19736_09 24 2021_Telecon.pdfpdfDecember 4, 2023951 KBpdf
IND 019736_S434_IND 19736_11 12 2021_Telecon.pdfpdfDecember 4, 2023809 KBpdf
IND 019736_S434_IND 19736_RAMACHANDRA_RE_ Request for Comments and Advice _ Proposal for adolesc.pdfpdfDecember 4, 2023714 KBpdf
FDA-CBER-2022-5812-0236791-0290515_125742-45_S211_M5_c4591001-A_1mth-D_adc19ef.zipzipDecember 4, 202333 MBzip
FDA-CBER-2022-5812-0290516-0346982_125742-45_S211_M5_c4591001-A_1mth-D_adfacevd.zipzipDecember 4, 202359 MBzip
FDA-CBER-2022-5812-0346983-0435012_125742-45_S211_M5_c4591001-S_1mth-D_suppface.zipzipDecember 4, 202311 MBzip
125742 45_S211_M5_c4591001 508 tables 12 15.pdfpdfDecember 4, 2023899 KBpdf
125742 45_S211_M5_c4591001 ad hoc label table.pdfpdfDecember 4, 2023746 KBpdf
019736_S434_M1_1571.pdfpdfDecember 4, 20232 MBpdf
019736_S434_M1_cover.pdfpdfDecember 4, 20232 MBpdf
019736_S434_M1_request comments 12 15 supp bla.pdfpdfDecember 4, 20233 MBpdf
019736_S596_M5_5354_c4591014 protocol amendment2.pdfpdfDecember 4, 20233 MBpdf
019736_S596_M5_5354_c4591014 protocol amendment2 track.pdfpdfDecember 4, 20233 MBpdf
019736_S596_M5_5354_c4591014 wi255886 wi235284 sap.pdfpdfDecember 4, 20233 MBpdf
019736_S798_M5_5354_c4591022 protocol clean.pdfpdfDecember 4, 20234 MBpdf
019736_S798_M5_5354_c4591022 protocol track.pdfpdfDecember 4, 20231 MBpdf
019736_S798_M5_5354_c4591022 sap clean.pdfpdfDecember 4, 20235 MBpdf
019736_S798_M5_5354_c4591022 sap track changes.pdfpdfDecember 4, 20232 MBpdf
125742 45_S211_M1_debarment.pdfpdfDecember 4, 2023792 KBpdf
125742 45_S211_M1_exclusivity claim.pdfpdfDecember 4, 2023635 KBpdf
125742 45_S211_M1_financial cert summary.pdfpdfDecember 4, 2023705 KBpdf
125742 45_S211_M1_lab 1448 1 1b annotated.pdfpdfDecember 4, 20234 MBpdf
125742 45_S211_M1_lab 1448 1 1b pkg insert clean.pdfpdfDecember 4, 20233 MBpdf
125742 45_S211_M1_lab 1448 1 1b pkg insert track.pdfpdfDecember 4, 20232 MBpdf
125742 45_S211_M1_pharmacovigilance plan.pdfpdfDecember 4, 20234 MBpdf
125742 45_S211_M1_pharmacovigilance plan track.pdfpdfDecember 4, 20233 MBpdf
125742 45_S211_M1_trans of oblig.pdfpdfDecember 4, 2023717 KBpdf
125742 45_S211_M2_clinical overview.pdfpdfDecember 4, 20234 MBpdf
125742 45_S211_M5_c4591001 interim ado adverse events.pdfpdfDecember 4, 202330 MBpdf
125742 45_S211_M5_c4591001 interim ado iec irb consent form.pdfpdfDecember 4, 20235 MBpdf
125742 45_S211_M5_c4591001 interim ado audit certificates.pdfpdfDecember 4, 2023795 KBpdf
125742 45_S211_M5_c4591001 interim ado compliance sensitive.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado demographics.pdfpdfDecember 4, 20235 MBpdf
125742 45_S211_M5_c4591001 interim ado discontinued patients.pdfpdfDecember 4, 20232 MBpdf
125742 45_S211_M5_c4591001 interim ado efficacy response sensitive.pdfpdfDecember 4, 20232 MBpdf
125742 45_S211_M5_c4591001 interim ado errata.pdfpdfDecember 4, 20232 MBpdf
125742 45_S211_M5_c4591001 interim ado excluded patients.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado interlab standard.pdfpdfDecember 4, 202311 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 iec irb consent form.pdfpdfDecember 4, 20235 MBpdf
125742 45_S211_M5_c4591001 interim ado invest signature.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado lab measurements sensitive.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 demographics.pdfpdfDecember 4, 20233 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 discontinued patients.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 errata.pdfpdfDecember 4, 20232 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 excluded patients.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 interlab standard.pdfpdfDecember 4, 202311 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 patient batches.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 invest signature.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 lab measurements.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 oversight committees.pdfpdfDecember 4, 202313 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 publications.pdfpdfDecember 4, 202312 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 protocol deviations.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 synopsis.pdfpdfDecember 4, 20234 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 randomization.pdfpdfDecember 4, 20233 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 report body.pdfpdfDecember 4, 20236 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 sap.pdfpdfDecember 4, 20235 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 sponsor signature.pdfpdfDecember 4, 20234 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 summary of changes.pdfpdfDecember 4, 20232 MBpdf
125742 45_S211_M5_c4591001 interim ado patient batches.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado protocol.pdfpdfDecember 4, 202373 MBpdf
125742 45_S211_M5_c4591001 interim ado publications.pdfpdfDecember 4, 202311 MBpdf
125742 45_S211_M5_c4591001 interim ado protocol deviations.pdfpdfDecember 4, 20231 MBpdf
125742 45_S211_M5_c4591001 interim ado randomization sensitive.pdfpdfDecember 4, 202332 MBpdf
125742 45_S211_M5_cumulative analysis post auth ae reports.pdfpdfDecember 4, 20233 MBpdf
125742 45_S211_M5_c4591001 interim ado report body.pdfpdfDecember 4, 20238 MBpdf
125742 45_S211_M5_c4591001 interim ado sap.pdfpdfDecember 4, 20235 MBpdf
125742 45_S211_M5_c4591001 interim ado sponsor signature.pdfpdfDecember 4, 20234 MBpdf
125742 45_S211_M5_c4591001 interim ado synopsis.pdfpdfDecember 4, 20234 MBpdf
125742 45_S211_M5_listing clinical sites.pdfpdfDecember 4, 202316 MBpdf
125742 45_S279_M1_response 14march2022.pdfpdfDecember 4, 2023810 KBpdf
125742 45_S211_M5_tabular listing.pdfpdfDecember 4, 20232 MBpdf
125742 45_S244_M1_enviromental assessment 12 15 age.pdfpdfDecember 4, 20231 MBpdf
125742 45_S252_M1_response 19jan2022.pdfpdfDecember 4, 2023784 KBpdf
125742 45_S211_M5_c4591001 interim ado mth6 adverse events.pdfpdfNovember 4, 20234 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 protocol.pdfpdfNovember 4, 202393 MBpdf
125742 45_S211_M5_c4591001 interim ado mth6 sample crf.pdfpdfNovember 4, 20234 MBpdf
125742 45_S211_M5_c4591001 interim ado sample crf.pdfpdfNovember 4, 20234 MBpdf
FDA CBER 2022 5812 0218992_125742 45_S211_M5_c4591001 S_6mth D_te.xptxptNovember 1, 20233 KBxpt
FDA CBER 2022 5812 0217344 0218981_125742 45_S211_M5_c4591001 S_6mth D_suppce.xptxptNovember 1, 20238 MBxpt
125742 45_S211_M5_c4591001 A_6mth report cci diabetes without comp 30oct2020.pdfpdfNovember 1, 2023627 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci diabetes with comp 06aug2021.pdfpdfNovember 1, 2023616 KBpdf
125742 45_S211_M5_c4591001 A_6mth comorbidity categories.pdfpdfNovember 1, 2023620 KBpdf
FDA CBER 2022 5812 0219056 0219220_125742 45_S211_M5_c4591001 A_6mth newlist c4591001 6k participants enrolled.zipzipNovember 1, 202343 KBzip
FDA CBER 2022 5812 0219036 0219055_125742 45_S211_M5_c4591001 A_6mth first c4591001 360 participants enrolled.zipzipNovember 1, 202318 KBzip
FDA CBER 2022 5812 0219019 0219034_125742 45_S211_M5_c4591001 A_6mth c4591001 subject list for 12 25 immuno.zipzipNovember 1, 202320 KBzip
FDA CBER 2022 5812 0219000 0219015_125742 45_S211_M5_c4591001 A_1mth c4591001 subject list for 12 25 immuno.zipzipNovember 1, 202317 KBzip
FDA CBER 2022 5812 0220427 0220463_125742 45_S211_M5_c4591001 A_6mth define2 0 0.xslxslNovember 1, 2023183 KBxsl
FDA CBER 2022 5812 0220390 0220426_125742 45_S211_M5_c4591001 A_1mth define2 0 0.xslxslNovember 1, 2023183 KBxsl
FDA CBER 2022 5812 0220118 0220389_125742 45_S211_M5_c4591001 A_6mth define.xmlxmlNovember 1, 2023931 KBxml
FDA CBER 2022 5812 0219816 0220117_125742 45_S211_M5_c4591001 A_1mth define.xmlxmlNovember 1, 20231 MBxml
FDA CBER 2022 5812 0219534 0219570_125742 45_S211_M5_c4591001 S_6mth define2 0 0.xslxslNovember 1, 2023183 KBxsl
FDA CBER 2022 5812 0219429 0219533_125742 45_S211_M5_c4591001 S_6mth define.xmlxmlNovember 1, 2023780 KBxml
FDA CBER 2022 5812 0219392 0219428_125742 45_S211_M5_c4591001 S_1mth define2 0 0.xslxslNovember 1, 2023183 KBxsl
FDA CBER 2022 5812 0219276 0219391_125742 45_S211_M5_c4591001 S_1mth define.xmlxmlNovember 1, 2023855 KBxml
FDA CBER 2022 5812 0219274 0219275_125742 45_S211_M5_c4591001 A_6mth report cci rheumatic 06aug2021.xlsxxlsxNovember 1, 202317 KBxlsx
FDA CBER 2022 5812 0219272 0219273_125742 45_S211_M5_c4591001 A_6mth report cci renal 30oct2020.xlsxxlsxNovember 1, 202317 KBxlsx
FDA CBER 2022 5812 0219270 0219271_125742 45_S211_M5_c4591001 A_6mth report cci pulmonary 30oct2020.xlsxxlsxNovember 1, 202317 KBxlsx
FDA CBER 2022 5812 0219268 0219269_125742 45_S211_M5_c4591001 A_6mth report cci periph vasc 30oct2020.xlsxxlsxNovember 1, 202318 KBxlsx
FDA CBER 2022 5812 0219267_125742 45_S211_M5_c4591001 A_6mth report cci peptic ulcer 30oct2020.xlsxxlsxNovember 1, 202315 KBxlsx
FDA CBER 2022 5812 0219266_125742 45_S211_M5_c4591001 A_6mth report cci mod sev liver 06aug2021.xlsxxlsxNovember 1, 202315 KBxlsx
FDA CBER 2022 5812 0219265_125742 45_S211_M5_c4591001 A_6mth report cci mild liver 30oct2020.xlsxxlsxNovember 1, 202316 KBxlsx
FDA CBER 2022 5812 0219264_125742 45_S211_M5_c4591001 A_6mth report cci mi 30oct2020.xlsxxlsxNovember 1, 202315 KBxlsx
FDA CBER 2022 5812 0219260 021926263_125742 45_S211_M5_c4591001 A_6mth report cci metastatic tumour 30oct2020.xlsxxlsxNovember 1, 202321 KBxlsx
FDA CBER 2022 5812 0219253 0219259_125742 45_S211_M5_c4591001 A_6mth report cci lymphoma 30oct2020.xlsxxlsxNovember 1, 202324 KBxlsx
FDA CBER 2022 5812 0219251 0219252_125742 45_S211_M5_c4591001 A_6mth report cci leukemia 30oct2020.xlsxxlsxNovember 1, 202318 KBxlsx
FDA CBER 2022 5812 0219249_125742 45_S211_M5_c4591001 A_6mth report cci diabetes without comp 30oct2020.xlsxxlsxNovember 1, 202316 KBxlsx
FDA CBER 2022 5812 0219248_125742 45_S211_M5_c4591001 A_6mth report cci diabetes with comp 06aug2021.xlsxxlsxNovember 1, 202315 KBxlsx
FDA CBER 2022 5812 0219247_125742 45_S211_M5_c4591001 A_6mth report cci dementia 30oct2020.xlsxxlsxNovember 1, 202315 KBxlsx
FDA CBER 2022 5812 0219246_125742 45_S211_M5_c4591001 A_6mth report cci chf 30oct2020.xlsxxlsxNovember 1, 202316 KBxlsx
FDA CBER 2022 5812 0219243 0219245_125742 45_S211_M5_c4591001 A_6mth report cci cerebrovascular 30oct2020.xlsxxlsxNovember 1, 202318 KBxlsx
FDA CBER 2022 5812 0219222 0219242_125742 45_S211_M5_c4591001 A_6mth report cci any malignancy 06aug2021.xlsxxlsxNovember 1, 202348 KBxlsx
FDA CBER 2022 5812 0219221_125742 45_S211_M5_c4591001 A_6mth report cci aids hiv 30oct2020.xlsxxlsxNovember 1, 202316 KBxlsx
FDA CBER 2022 5812 0219035_125742 45_S211_M5_c4591001 A_6mth comorbidity categories.xlsxxlsxNovember 1, 202313 KBxlsx
FDA CBER 2022 5812 0219017 0219018_125742 45_S211_M5_c4591001 A_6mth bmi 12 15 scale.xlsxxlsxNovember 1, 202314 KBxlsx
FDA CBER 2022 5812 0219016_125742 45_S211_M5_c4591001 A_6mth 201114 hiv preferred terms.xlsxxlsxNovember 1, 202313 KBxlsx
FDA CBER 2022 5812 0218998 0218999_125742 45_S211_M5_c4591001 S_6mth D_tv.xptxptNovember 1, 202316 KBxpt
FDA CBER 2022 5812 0218996 0218997_125742 45_S211_M5_c4591001 S_6mth D_ts.xptxptNovember 1, 202340 KBxpt
FDA CBER 2022 5812 0218993 0218995_125742 45_S211_M5_c4591001 S_6mth D_ti.xptxptNovember 1, 202337 KBxpt
FDA CBER 2022 5812 0218991_125742 45_S211_M5_c4591001 S_6mth D_ta.xptxptNovember 1, 20238 KBxpt
FDA CBER 2022 5812 0218982 0218990_125742 45_S211_M5_c4591001 S_6mth D_suppcm.xptxptNovember 1, 202344 KBxpt
FDA CBER 2022 5812 0219250_125742 45_S211_M5_c4591001 A_6mth report cci hemiplegia 30oct2020.xlsxxlsxNovember 1, 202315 KBxlsx
FDA CBER 2022 5812 0217327_125742 45_S211_M5_c4591001 S_6mth D_ie.xptxptNovember 1, 20234 KBxpt
FDA CBER 2022 5812 0217325 0217326_125742 45_S211_M5_c4591001 S_6mth D_di.xptxptNovember 1, 202313 KBxpt
FDA CBER 2022 5812 0217321 0217324_125742 45_S211_M5_c4591001 S_6mth D_cm.xptxptNovember 1, 202363 KBxpt
FDA CBER 2022 5812 0217319 0217320_125742 45_S211_M5_c4591001 S_1mth D_tv.xptxptNovember 1, 202316 KBxpt
FDA CBER 2022 5812 0217317 0217318_125742 45_S211_M5_c4591001 S_1mth D_ts.xptxptNovember 1, 202340 KBxpt
FDA CBER 2022 5812 0217314 0217316_125742 45_S211_M5_c4591001 S_1mth D_ti.xptxptNovember 1, 202337 KBxpt
FDA CBER 2022 5812 0217313_125742 45_S211_M5_c4591001 S_1mth D_te.xptxptNovember 1, 20233 KBxpt
FDA CBER 2022 5812 0217312_125742 45_S211_M5_c4591001 S_1mth D_ta.xptxptNovember 1, 20238 KBxpt
FDA CBER 2022 5812 0217301 0217311_125742 45_S211_M5_c4591001 S_1mth D_supppr.xptxptNovember 1, 202372 KBxpt
FDA CBER 2022 5812 0217299 0217300_125742 45_S211_M5_c4591001 S_1mth D_supppe.xptxptNovember 1, 202312 KBxpt
FDA CBER 2022 5812 0217294 0217298_125742 45_S211_M5_c4591001 S_1mth D_suppmo.xptxptNovember 1, 202365 KBxpt
FDA CBER 2022 5812 0217099 0217293_125742 45_S211_M5_c4591001 S_1mth D_relrec.xptxptNovember 1, 2023567 KBxpt
FDA CBER 2022 5812 0217098_125742 45_S211_M5_c4591001 S_1mth D_pr.xptxptNovember 1, 202319 KBxpt
FDA CBER 2022 5812 0217090 0217097_125742 45_S211_M5_c4591001 S_1mth D_mo.xptxptNovember 1, 202376 KBxpt
FDA CBER 2022 5812 0217053 0217089_125742 45_S211_M5_c4591001 S_1mth D_ie.xptxptNovember 1, 2023480 KBxpt
FDA CBER 2022 5812 0217329 0217343_125742 45_S211_M5_c4591001 S_6mth D_relrec.xptxptNovember 1, 202345 KBxpt
FDA CBER 2022 5812 0217328_125742 45_S211_M5_c4591001 S_6mth D_mo.xptxptNovember 1, 20234 KBxpt
125742 45_S211_M5_c4591001 A_6mth report cci pulmonary 30oct2020.pdfpdfNovember 1, 2023630 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci periph vasc 30oct2020.pdfpdfNovember 1, 2023632 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci peptic ulcer 30oct2020.pdfpdfNovember 1, 2023625 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci mod sev liver 06aug2021.pdfpdfNovember 1, 2023617 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci mild liver 30oct2020.pdfpdfNovember 1, 2023628 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci mi 30oct2020.pdfpdfNovember 1, 2023624 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci metastatic tumour 30oct2020.pdfpdfNovember 1, 2023636 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci lymphoma 30oct2020.pdfpdfNovember 1, 2023640 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci leukemia 30oct2020.pdfpdfNovember 1, 2023631 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci hemiplegia 30oct2020.pdfpdfNovember 1, 2023626 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci dementia 30oct2020.pdfpdfNovember 1, 2023626 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci chf 30oct2020.pdfpdfNovember 1, 2023628 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci cerebrovascular 30oct2020.pdfpdfNovember 1, 2023632 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci any malignancy 06aug2021.pdfpdfNovember 1, 2023688 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci aids hiv 30oct2020.pdfpdfNovember 1, 2023629 KBpdf
125742 45_S211_M5_c4591001 A_6mth newlist c4591001 6k participants enrolled v3 17sep2020.pdfpdfNovember 1, 2023845 KBpdf
125742 45_S211_M5_c4591001 A_6mth first c4591001 360 participants enrolled v1 13aug20 update.pdfpdfNovember 1, 2023607 KBpdf
125742 45_S211_M5_c4591001 A_6mth c4591001 subject list for 12 25 immuno analysis 27jan2021.pdfpdfNovember 1, 2023620 KBpdf
125742 45_S211_M5_c4591001 A_6mth bmi 12 15 scale.pdfpdfNovember 1, 2023627 KBpdf
125742 45_S211_M5_c4591001 A_6mth 201114 hiv preferred terms.pdfpdfNovember 1, 2023602 KBpdf
125742 45_S211_M5_c4591001 A_1mth c4591001 subject list for 12 25 immuno analysis 27jan2021.pdfpdfNovember 1, 2023640 KBpdf
FDA CBER 2022 5812 0163599_125742 45_S211_M5_c4591001 S_1mth D_di.xptxptNovember 1, 202312 KBxpt
FDA CBER 2022 5812 0163598_125742 45_S211_M5_c4591001 S_1mth D_dd.xptxptNovember 1, 202315 KBxpt
125742 45_S211_M5_c4591001 A_6mth report cci rheumatic 06aug2021.pdfpdfNovember 1, 2023621 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci renal 30oct2020.pdfpdfNovember 1, 2023629 KBpdf
FDA-CBER-2022-5812-0163600-0217052_125742-45_S211_M5_c4591001-S_1mth-D_face.zipzipNovember 1, 202352 MBzip
125742 45_S211_M5_c4591001 A_6mth report cci diabetes without comp 30oct2020.pdfpdfOctober 1, 2023627 KBpdf
125742 45_S211_M5_c4591001 A_6mth report cci diabetes with comp 06aug2021.pdfpdfOctober 1, 2023616 KBpdf
125742 45_S211_M5_c4591001 A_6mth comorbidity categories.pdfpdfOctober 1, 2023620 KBpdf
FDA CBER 2022 5812 0140175 0143444_125742 45_S211_M5_c4591001 S_1mth D_suppmb.zip (xpt)zipOctober 1, 2023444 KBzip
FDA CBER 2022 5812 0136897 0140174_125742 45_S211_M5_c4591001 S_1mth D_mb.zip (xpt)zipOctober 1, 20232 MBzip
FDA CBER 2022 5812 0133244 0136896_125742 45_S211_M5_c4591001 S_1mth D_supplb.zip (xpt)zipOctober 1, 2023522 KBzip
FDA CBER 2022 5812 0129532 0133243_125742 45_S211_M5_c4591001 S_1mth D_suppdv.zip (xpt)zipOctober 1, 2023631 KBzip
FDA CBER 2022 5812 0124856 0129531_125742 45_S211_M5_c4591001 S_1mth D_se.zip (xpt)zipOctober 1, 20232 MBzip
FDA CBER 2022 5812 0119933 0124855_125742 45_S211_M5_c4591001 S_1mth D_suppae.zip (xpt)zipOctober 1, 2023873 KBzip
FDA CBER 2022 5812 0115008 0119932_125742 45_S211_M5_c4591001 S_1mth D_suppmh.zip (xpt)zipOctober 1, 2023619 KBzip
FDA CBER 2022 5812 0107916 0115007_125742 45_S211_M5_c4591001 S_1mth D_ds.zip (xpt)zipOctober 1, 20233 MBzip
125742 45_S364_M1_356h.pdfpdfOctober 1, 20235 MBpdf
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125742 45_S211_M1_356h.pdfpdfOctober 1, 20234 MBpdf
FDA CBER 2022 5812 0160383 0163460_125742 45_S211_M5_c4591001 A_1mth D_adds.zip (xpt)zipOctober 1, 20237 MBzip
FDA CBER 2022 5812 0152173 0160382_125742 45_S211_M5_c4591001 A_1mth D_adsympt.zip (xpt)zipOctober 1, 20236 MBzip
FDA CBER 2022 5812 0149731 0152172_125742 45_S211_M5_c4591001 S_1mth D_suppdm.zip (xpt)zipOctober 1, 2023332 KBzip
FDA CBER 2022 5812 0146648 0149730_125742 45_S211_M5_c4591001 S_1mth D_suppds.zip (xpt)zipOctober 1, 2023389 KBzip
FDA CBER 2022 5812 0143445 0146647_125742 45_S211_M5_c4591001 S_1mth D_ex.zip (xpt)zipOctober 1, 20232 MBzip
FDA CBER 2022 5812 0099773 0107915_125742 45_S211_M5_c4591001 S_1mth D_suppvs.zip (xpt)zipSeptember 1, 2023917 KBzip
FDA CBER 2022 5812 0089294 0099772_125742 45_S211_M5_c4591001 S_1mth D_vs.zip (xpt)zipSeptember 1, 20238 MBzip
FDA CBER 2022 5812 0082642 0089293_125742 45_S211_M5_c4591001 S_1mth D_sv.zip (xpt)zipSeptember 1, 20232 MBzip
FDA CBER 2022 5812 0073164 0082641_125742 45_S211_M5_c4591001 S_1mth D_ce.zip (xpt)zipSeptember 1, 20239 MBzip
125742 45_S314_M1_cover.pdfpdfSeptember 1, 2023698 KBpdf
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125742 45_S211_M5_woodruff rc 2021.pdfpdfSeptember 1, 2023841 KBpdf
125742 45_S211_M5_van dyke me 2020.pdfpdfSeptember 1, 2023671 KBpdf
125742 45_S211_M5_tsankov bk 2021.pdfpdfSeptember 1, 20231 MBpdf
125742 45_S211_M5_tong jy 2020.pdfpdfSeptember 1, 2023778 KBpdf
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125742 45_S211_M5_ludvigsson jp 2020.pdfpdfSeptember 1, 2023849 KBpdf
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125742 45_S211_M5_c4591001 A_6mth P adsl sas.pdfpdfSeptember 1, 2023971 KBpdf
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125742 45_S211_M5_c4591001 A_1mth P adva s001 gmr ped ev eval sas.pdfpdfSeptember 1, 2023683 KBpdf
125742 45_S211_M5_c4591001 A_1mth P adsympt sas.pdfpdfSeptember 1, 2023678 KBpdf
125742 45_S211_M5_c4591001 A_1mth P adsl sas.pdfpdfSeptember 1, 2023908 KBpdf
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125742 45_S211_M5_bhaskaran k 2021.pdfpdfSeptember 1, 20232 MBpdf
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125742 45_S211_M2_introduction.pdfpdfSeptember 1, 20232 MBpdf
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125742 45_S211_M5_c4591001 A_6mth P adxb sas.pdfpdfSeptember 1, 2023638 KBpdf
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FDA CBER 2022 5812 0055227 0071265_125742 45_S211_M5_c4591001 S_1mth D_suppex.zip (xpt)zipAugust 1, 20233 MBzip
FDA CBER 2022 5812 0039188 0055226_125742 45_S211_M5_c4591001 S_1mth D_suppec.zip (xpt)zipAugust 1, 20233 MBzip
FDA CBER 2022 5812 0035985 0039187_125742 45_S211_M5_c4591001 S_1mth D_ec.zip (xpt)zipAugust 1, 20232 MBzip
FDA CBER 2022 5812 0020040 0035984_125742 45_S211_M5_c4591001 S_6mth D_suppface.zip (xpt)zipJuly 3, 20232 MBzip
FDA CBER 2022 5812 0010641 0020039_125742 45_S211_M5_c4591001 S_6mth D_face.zip (xpt)zipJuly 3, 20238 MBzip
FDA CBER 2022 5812 0000001 0010640_125742 45_S211_M5_c4591001 S_1mth D_suppce.zip (xpt)zipJuly 3, 20231 MBzip
125742 45_S211_M5_c4591001 interim ado oversight committees.pdfpdfJanuary 4, 202314 MBpdf