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FORM FDA 1571 (0 /1 )35(9,286 (',7,21 2%62/(7( Page 1 of 12. For Originals, is the product a combination product (21 CFR 3.2(e))?Next Page Export Data Import Data Reset Form DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration INVESTIGATIONAL NEW DRUG APPLICATION (IND) (Title 21, Code of Federal Regulations (CFR) Part 312) 5. Name of Drug (Include all available names: Trade, Generic, Chemical, or Code) 8. Phase of Clinical Investigation to be conducted 11. This…
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CONCURRENCE PAGE This page must be uploaded into the EDR. Do NOT send this page to the applicant. Do NOT post this page to the Biological Approvals website. Application #: STN: BL 125742 /8 Communication Name: Notification Communication ID: WR LTR- OBE Safety Related Drafted by: Christopher Okoye : 09/27/2021 Review /Concurrence History: Craig Zinderman: 09/29/2021 Lori Austin -Hansberry : 09/29/2021 cc: CBER Electronic Repository END OF…
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FDA-CBER-2021-5683-1072439 FDA-CBER-2021-5683-1072440
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CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent Pediatric Study Template (01 -Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version Number (Study /Country/Site) : [1/0/0] Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing (allage groups) 13 Sep 2021 Protocol No. C4591007/PFIZER CONFIDENTIALPage: 1of 7 We would like to tell you about a research study and see if you would like to take part. You will need to read this…
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CT05 -GSOP -RF04 7.0PHA SE 3 CLINICA L STUDY INFORMED CONSENT TEMPL ATE01-Jul-2019 Protocol Number: C4591020 ICD Version Date : 02 Feb 2021 Study Country SiteLanguage: English Center ID: Not Applicable Country: US ICD Derived From: C4591020, ICD Version Date: 20 -Jan-2021 CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version (Study/ Country/Site) 2/2/0, 02…
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CT05 -GSOP -RF05 7.0PHA SE 1/2/3INFORMED CONSENT PEDIA TRIC STUDY TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date : 13Sep 2021 Phase 2/3 Placebo -Controlled Selected Dose Study Country SiteLanguage: English Center ID: N/A Country: N/A ICD Derived From: 06 Aug 2021 CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent Pediatric Study Template (01 -Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version Number…
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From:Gottschalk, Laura Sent:Monday, September 20, 2021 3:05 PM To:Patel, Amit <[email protected]> Cc:Devlin, Carmel M <[email protected]>; Harkins Tull, Elisa <[email protected]>; ; [email protected]; Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]> Subject:STN 125742/9 -COVID-19 Vaccine, mRNA (COMIRNATY): Product Correspondence -CBER response to plan for reporting Biologic Product Deviation Reports …
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CT05 -GSOP -RF04 7.0PHA SE 2/3CLINICA L STUDY INFORMED CONSENT TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date : (Study): Phase 2 3Lower Dose Evaluation (Adult) V1 09Aug2021 Study Country SiteLanguage: English Center ID: N/A Country: N/A ICD Derived From: N/A CT05-GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version Date :(Study ): [1/0/0] Phase 2/3…
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CT05 -GSOP -RF04 7.0PHA SE 1CLINICA L STUDY INFORMED CONSENT TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date : (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021 Study Country SiteLanguage: English Center ID: N/A Country: N/A ICD Derived From: N/A CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version Date (Study): Phase 1 Lower Dose…
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From:Gottschalk, Laura Sent:Wednesday, September 22, 2021 9:12 AM To:Patel, Amit <[email protected]> Cc:Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]>; Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; Stafford, Adrienne Kaye <[email protected]>; Pelt, Rich R < > Subject:RE: [EXTERNAL] RE: STN 125742/5 -COVID-19 Vaccine, mRNA (COMIRNATY): Product Correspondence -CBER…
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CT05 -GSOP -RF05 7.0PHA SE [1/2/3] INFORMED CONSENT PEDIA TRIC STUDY TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date :09Aug2021 Phase 2 /3 Lower Dose Evaluation , Parental Consent Study Country SiteLanguage: Center ID: N/A Country: N/A ICD Derived From: N/A CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent Pediatric Study Template (01 -Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version Number (Study/Country/Site) :…
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CT05 -GSOP -RF05 7.0PHA SE [1/2/3] INFORMED CONSENT PEDIA TRIC STUDY TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date :09Aug2021 Phase 1 Lower Dose Evaluation, Parental Consent Study Country SiteLanguage: Center ID: N/A Country: N/A ICD Derived From: N/A CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent Pediatric Study Template ( 01-Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version Number (Study/Country/Site) :…
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Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 30August2021 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 AN…
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&RQWLQXDWLRQ 3DJH IRU 1H[W 3DJH ([SRUW 'DWD ,PSRUW 'DWD 5HVHW )RUP '(3$570(17 2) +($/7+$1' +80$1 6(59,&(6 Food and Drug Administration $33/,&$7,21 72 0$5.(7$1(: 25$%%5(9,$7(' 1(: '58* 25 %,2/2*,& )25 +80$1 86( (Title 21, Code of Federal Regulations, Parts 314 & 601) 3. Telephone Number (Include country code if applicable and area code) 9. Established Name (e.g., proper name, USP/USAN name) 10. Proprietary Name (Trade Name) (If any) 11. Chemical/Biochemical/Blood Product Name (If any) …
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From: Gemignani, Helen S To: [email protected] Subject: COMIRNATY STN 125742 - PMR/PMC Communications Date: Thursday, September 30, 2021 4:49:00 PM Attachments: image002.png Good afternoon Dr. Patel, We are in receipt of your 8/30/2021, PMR/PMC Correspondence Status Update submission, to your COMIRNATY BLA. This submission notified the BLA of the submission of study protocols to the IND for [ PMR# 4, Study C4591009] and [ PMC# 12 , Study C4591012]. Please note, in the BLA Approval…
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From: Patel, Amit To: Okoye, Christopher Cc: Austin-Hansberry, Lori Subject: [EXTERNAL] RE: FDA Waiver - COMIRNATY Date: Wednesday, September 29, 2021 5:04:08 PM Attachments: image001.png CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe. Hi Christopher, I confirm receipt. Thanks Amit From: Okoye, Christopher <[email protected]> Sent: Wednesday, September 29, 2021…
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VACCINE RESEARCH SOP PEARL RIVER, NY TITLE: Data Review Procedures for Direct Luminex Immunoassays in LIMS v6Doc. Number: VR-SOP-LC-11120 Version: 3.0 Doc. Alias: NA PFIZER CONFIDENTIAL Page 1 TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 1. HISTORICAL REVI SION SUMMARY ................................ ................................ ..............3 2. PURPOSE…
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CT05 -GSOP -RF05 7.0PHA SE 1/2/3INFORMED CONSENT PEDIA TRIC STUDY TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date : 10 Sep 2021 Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing Study Country SiteLanguage: English Center ID: N/A Country: N/A ICD Derived From: N/A CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent Pediatric Study Template (01 -Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version Number…
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CT05 -GSOP -RF05 7.0PHA SE 1/2/3INFORMED CONSENT PEDIA TRIC STUDY TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date : 06Aug 2021 Phase 2/3 Placebo -Controlled Selected Dose Study Country SiteLanguage: English Center ID: N/A Country: N/A ICD Derived From: 02 Jul 2021 CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent Pediatric Study Template (01 -Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version Number…
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20993 CENTER FOR BIOLOGICS EVALUATION AND RESEARCH OFFICE OF VACCINES RESEARCH AND REVIEW DIVISION OF VACCINES AND RELATED PRODUCTS APPLICATIONS DATE: September 10, 2021 PAGES: 4 TO: BioNTech RNA Pharmaceuticals GmbH/Pfizer. Inc. Attention: Amit Patel 235 East 42ndStreet New York, NY 10017 Phone: 214-918-5262 Fax number: 845-474-3500 E-mail: [email protected] FROM: Laura Gottschalk, Ph.D.…