Pfizer Documents (PHMPT/FDA)
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· 125 pages
Page 1 of 125 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951256 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 603 pages
Page 1 of 603 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951228 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 147 pages
Page 1 of 147 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951204 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 917 pages
Page 1 of 917 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951197 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 136 pages
Page 1 of 136 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951180 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 220 pages
Page 1 of 220 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951173 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 164 pages
Page 1 of 164 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951141 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 177 pages
Page 1 of 177 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951134 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 195 pages
Page 1 of 195 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951125 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 214 pages
Page 1 of 214 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951107 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 406 pages
Page 1 of 406 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway Subject No: 10971061 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,…
Pfizer Documents (PHMPT/FDA)
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FDA-CBER-2021-5683-0972182 FDA-CBER-2021-5683-0972183 FDA-CBER-2021-5683-0972184 FDA-CBER-2021-5683-0972185 FDA-CBER-2021-5683-0972186 FDA-CBER-2021-5683-0972187 FDA-CBER-2021-5683-0972188 FDA-CBER-2021-5683-0972189 FDA-CBER-2021-5683-0972190 FDA-CBER-2021-5683-0972191 FDA-CBER-2021-5683-0972192 FDA-CBER-2021-5683-0972193 FDA-CBER-2021-5683-0972194 FDA-CBER-2021-5683-0972195 FDA-CBER-2021-5683-0972196 FDA-CBER-2021-5683-0972197 FDA-CBER-2021-5683-0972198 FDA-CBER-2021-5683-0972199…
Pfizer Documents (PHMPT/FDA)
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· 252 pages
Page 1 of 252 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway Subject No: 10971084 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,…
Pfizer Documents (PHMPT/FDA)
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· 179 pages
Page 1 of 179 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1072 Site Name: (1072) Optimal Research, LLC Subject No: 10721007 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 478 pages
Page 1 of 478 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1072 Site Name: (1072) Optimal Research, LLC Subject No: 10721037 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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From: Naik, Ramachandra Sent: Tuesday, July 13, 2021 5:11 PM To: Harkins Tull, Elisa < [email protected] > Cc: Gottschalk, Laura < [email protected] >; Smith, Michael (CBER) <[email protected] >; Aghajani Memar, Neda < [email protected] >; Devlin, Carmel M <[email protected] > Subject: STN 125742/0 - COMIRNATY – CBER comments regarding exception or alternative to the requirement that products in multiple -dose vials include a…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Tuesday, July 6, 2021 9:00 AM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: Your proposed proprietary name, COMIRNATY, is Acceptable Elisa, In consultation with CBER’s Advertising and Promotional Labeling…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 23August 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Pfizer Documents (PHMPT/FDA)
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· 8 pages
Study C4591001 Clinical Study Data Reviewer’s Guide This document is confidential Page 1 of 8 Clinical Study Data Reviewer’s Guide for Sequencing Data Analysis BLA Analysis for Participants ≥16 Years of Age BioNTech SE and PFIZER INC. Study C4591001 090177e19733f38a\Final\Final On: 04-Jun-2021 01:50 (GMT) FDA-CBER-2021-5683-1007493 Study C4591001 Clinical Study Data Reviewer’s Guide This document is confidential Page 2 of 8 Clinical Data Reviewer…
Pfizer Documents (PHMPT/FDA)
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· 12 pages
Analysis Data Reviewer Guide for BLA Sequencing Data Analysis BioNTech SE and PFIZER INC. Study C4591001 090177e1973485a7\Final\Final On: 04-Jun-2021 19:02 (GMT) FDA-CBER-2021-5683-1007481 Study C4591001 Analysis Data Reviewer’s Guide 2 ANALYSIS DATA REVIEWER GUIDE REVISION HISTORY Version Summary of Major Change(s) and Impact Version Date 1.0 First approved version of Analysis Data Reviewer Guide for Sequencing data Analysis 03-Jun-2021 …