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PFIZER CONFIDENTIAL Page 1 Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42nd Street New York, NY 10017 Global Product Development 15 April 2021 THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR REGISTRATION OF PRODUCTS FOR PFIZER INC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, IN WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF…
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PFIZER CONFIDENTIAL Page 1Global Regulatory Affairs -Vaccines Pfizer Inc. 500 Arcola Road Collegeville , PA19426 -3982 Global Product Developm ent 15 January 2021THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONL Y IN CONNECTION WITH THE LICENSING AND/OR REGI STRATION OF PRODUCTS FOR PFIZER INC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, I N WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN…
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PFIZER CONFI DENTIAL Page 1 Pfizer Inc 500 Arcola Road Collegeville, PA 19426 Global Product Development 25August2020 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue…
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PFIZER CONFIDENTIAL Page 1 Global Regulatory Affairs - Vaccines Pfizer Inc. 235 East 42nd Street New York , NY 10017 Global Product Development 16 June 2021 THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR REGISTRATION OF PRODUCTS FOR PFIZER I NC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, IN WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN …
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FDA-CBER-2021-5683-1072736 SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212 Page 2 090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT) (b) (4) FDA-CBER-2021-5683-1072737 SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212 Page 3 090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT) (b) (4) FDA-CBER-2021-5683-1072738 SARS-CoV-2 dLIA Precision Qualification Data for Documentation…
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PFIZER CONFIDENTIAL Page 1Global Regulatory Affairs - Vaccines Pfizer Inc. 235 East 42nd Street New York, NY 10017 Global Product Developm ent 14 May 2021THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONL Y IN CONNECTION WITH THE LICENSING AND/OR REGI STRATION OF PRODUCTS FOR PFIZER INC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, I N WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF…
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PFIZER CONFIDENTIAL Page 1Global Regulatory Affairs - Vaccines Pfizer Inc. 235 East 42nd Street New York, NY 10017 Global Product Developm ent 15 July 2021THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONL Y IN CONNECTION WITH THE LICENSING AND/OR REGI STRATION OF PRODUCTS FOR PFIZER INC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, I N WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF…
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PFIZER CONFIDENTIAL Page 1Global Regulatory Affairs - Vaccines Pfizer Inc. 235 East 42nd Street New York, NY 10017 Global Product Developm ent 15 June 2021THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONL Y IN CONNECTION WITH THE LICENSING AND/OR REGI STRATION OF PRODUCTS FOR PFIZER INC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, I N WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF…
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PFIZER CONFIDENTIAL Page 1Global Regulatory Affairs - Vaccines Pfizer Inc. 235 East 42nd Street New York, NY 10017 Global Product Developm ent 14 August 2021THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONL Y IN CONNECTION WITH THE LICENSING AND/OR REGI STRATION OF PRODUCTS FOR PFIZER INC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, I N WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF…
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From: Smith, Michael (CBER) Sent: Tuesday, May 18, 2021 6:02 PM 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: IR RE datasets Elisa , Neda and Carmel, The BLA review committee has the below IR for you regarding datasets. Reference is made to…
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PFIZER CONFIDENTIAL Page 1Global Regulatory Affairs - Vaccines Pfizer Inc. 235 East 42nd Street New York, NY 10017 Global Product Developm ent 15 September 2021THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONL Y IN CONNECTION WITH THE LICENSING AND/OR REGI STRATION OF PRODUCTS FOR PFIZER INC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, I N WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT…
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31© World Health Organization WHO Technical Report Series, No. 927, 2005 Annex 1 WHO guidelines on nonclinical evaluation of vaccines This document provides guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the nonclinical evaluation of vac-cines by outlining the international regulatory expectations in this area. Itshould be read in conjunction with the Guidelines on clinical evaluation ofvaccines: regulatory expectations (1), in order to complete the…
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31© World Health Organization WHO Technical Report Series, No. 927, 2005 Annex 1 WHO guidelines on nonclinical evaluation of vaccines This document provides guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the nonclinical evaluation of vac-cines by outlining the international regulatory expectations in this area. Itshould be read in conjunction with the Guidelines on clinical evaluation ofvaccines: regulatory expectations (1), in order to complete the…
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Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 20July2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research DocumentControl 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…
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Pfizer Global Regulatory Affairs Pfizer Inc. 235East 42ndStreet/New York, NY 10017 -5755 Global Product Developm ent 18February 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 S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING …
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Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 14September 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biologics Evaluation and Research DocumentControl 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…
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Pfizer Inc. 235 East 42ndStreet New York, NY 10017 Global Product Developm ent 29January2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research DocumentControl 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 REGISTRATION OF PRODUCTS FOR PFIZE…
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The official version of this form is located in the electronic document management system. This document was created based on QMS04 -GSOP -SD-GL06 5.0 CMCD Forms Template WORD 01 -Oct-2020. TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site) Sponsor Consent Version Number (Study/ Country/Site) : [1/0/0] 09Aug 2021 Phase 2/3 Lower Dose Evaluation, Older Assent PFIZER CONFIDENTIALPage 1 of 8We would like to tell you about a research study and see if you would like to take part. …
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Template updated_v4_20180901_lahCBER/OBE/DE Waiver Request Review Memo I. Completed by Waiver Coordinator Product/STN/Reviewer: Product Name STN/NDA Approval Date Reviewer COMIRNATY125742/823-Aug-2021 D. Thompson CBER Submission Receipt Date: September15, 2021 Review Memo Action Due Date: October 18, 2021 Type of request : PBRER Waiver Request Request to Change Reporting Period Other: Lot distribution Waiver Request II. Completedby Medical Officer Reviewsummary:The sponsor requested…
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Template updated_v4_20180901_lahCBER/OBE/DE Waiver Request Review Memo I. Completed by Waiver Coordinator Product/STN/Reviewer: Product Name STN/NDA Approval Date Reviewer COMIRNATY125742/823-Aug-2021 D. Thompson CBER Submission Receipt Date: September15, 2021 Review Memo Action Due Date: October 18, 2021 Type of request : PBRER Waiver Request Request to Change Reporting Period Other: Lot distribution Waiver Request II. Completedby Medical Officer Reviewsummary:The sponsor requested…