Pfizer Documents (PHMPT/FDA)
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· 21 pages
Url flat annotations are provided at first mention Drives to USPI (16+) - http:// labeling.pfizer.co m/ ShowLabeling.as px? id=15623 Drive to https:// www.cvdvaccine- us.com/faqs#diff-fda- eua Drives to http:// labeling.pfizer.com/ ShowLabeling.aspx? id=14471&format=pdf FDA-CBER-2021-5683-0951527 FDA-CBER-2021-5683-0951528 FDA-CBER-2021-5683-0951529 FDA-CBER-2021-5683-0951530 FDA-CBER-2021-5683-0951531 FDA-CBER-2021-5683-0951532 FDA-CBER-2021-5683-0951533 FDA-CBER-2021-5683-0951534…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 15September 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…
Pfizer Documents (PHMPT/FDA)
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BNT162b2 1.12.5 Request for a Waiver –Lot Distribution Reports PFIZER CONFIDENTIAL Page 1WAIVER REQUEST –LOT DISTRIBUTION REPORTS Per 21 CFR 600.81 a Lot Distribution Report (L DR) is to be provided in electronic format every six months or at times other than every 6 months as determined at the time of approval. For COMIRNATY, the LDR was requested monthly per the BLA approval issued on 23 August 2021. The purpose of this General C orrespondence is to request an extension of the first…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 15September 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…
Pfizer Documents (PHMPT/FDA)
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BNT162b2 1.12.4 Request for Comments and Advice –BPDR Reporting PFIZER CONFIDENTIAL Page 1BIOLOGIC PRODUCT DEV IATION REPORTING ( BPDR) –COMPANY POSITION In line with the BLA licenseapproval, 21 CFR 600.14 regulations, and previous communication that Biologic Product Deviation Reports (BPDRs) were not required for the Pfizer-BioNTech COVID- 19 Vaccine authorized under the EUA the following approach will be taken: A BPDR is required and would be issued for COVID -19 Vaccine lots…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 21 September 2021 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 WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE…
Pfizer Documents (PHMPT/FDA)
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FDA-CBER-2021 5683 0951556 Digitally signed by DN o=Pfizer Inc cn Reason I am signing on behalf of Donna Boyce Location Date 2021.09.2 09 2 11 0800' (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-0951557
Pfizer Documents (PHMPT/FDA)
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· 8 pages
1 Revised: 22September 2021VACCINE INFORMA TION FACT SHEET FOR REC IPIENTS AND CA REGIVERS ABOUT COMIRNA TY (COVID -19 VA CCINE, mRNA ) ANDPFIZER -BIONTECH COVID -19 VACCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) You are being offered either COMIRNA TY (COVID -19 Vaccine, mRNA ) or the Pfizer-BioNTech COVID- 19 Vaccine to prevent Coronavirus Disease 2019 (COVID -19)caused by S ARS -CoV-2. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet…
Pfizer Documents (PHMPT/FDA)
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· 48 pages
Revised: 22 September 2021 1 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS) EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER -BIONTECH COVID- 19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID -19) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer -BioNTech COVID- 19 Vaccine, for active immunization to prevent COVID -19 in individuals 12…
Pfizer Documents (PHMPT/FDA)
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· 4 pages
for storage, handling, and preparation of the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY® (COVID-19 Vaccine, mRNA)*CHECKLIST 1 of 4Please see Indication, Authorized Use, and Important Safety Information on page 4. Before administration of the vaccine, please see full Prescribing Information (16+ years of age), EUA Fact Sheet for Vaccination Providers (12+ years of age), and Recipients and Caregivers Fact Sheet (12+ years of age).Important Safety Information Known…
Pfizer Documents (PHMPT/FDA)
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LOW DEAD-VOLUME (LDV) SYRINGES AND/OR NEEDLES GUIDE * The licensed COMIRNATY® vaccine has the same formulation as the authorized vaccine Pfizer-BioNTech COVID-19 Vaccine, and they can be used interchangeably without presenting any safety or effectiveness concerns. Although they may be manufactured in different facilities, the products offer the same safety and effectiveness. 1 of 3Please see Indication, Authorized Use, and Important Safety Information on page 3. Before administration of…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
FDA-CBER-2021 5683 0951621 D gi a ly signed by DN c= l New York o Pf zer Inc. ou=PPLS - College lle ou=Submissions and Operations Support cn Reason I am signing on behalf Donna Boyce Location Date 2021 09.2 1 22 50 0 '00' (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-0951622
Pfizer Documents (PHMPT/FDA)
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· 20 pages
1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMI RNATY safely and effectively. See full prescribing information for COMIRNATY . COMIRNATY®(COVID -19 Vaccine , mRNA )suspension for injection , for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMI RNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVI D-19) caused…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 18August2021 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 AND/OR…
Pfizer Documents (PHMPT/FDA)
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· 6 pages
BNT162b2 BLA STN 125742 /0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 1BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to CBER 17 August 2021 Follow -up Information Request Regarding Safety -Related Postmarketing Requirement/Postmarketing Commitment S tudies 18August 2021 090177e197d79d0b\Approved\Approved On: 18-Aug-2021 15:42 (GMT) FDA-CBER-2021-5683-0950362 BNT162b2 BLA STN 125742 /0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 2TABLE OF…
Pfizer Documents (PHMPT/FDA)
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Plant Line(s): RM Line (various)Dwg. No. N/A10mL PLASTIC VIAL Reference: 3C die line CC11545 Document Owner: J. CottonVersion: N/ADRAWING TEMPLATE Original Source:Dwg. No. DWG-50061378 Version: V02NOTES: 1. Commodity number to be 8 point OCRB Medium black on white background.FOR SERIALIZED 5.3437 x 5.3437 x 1.25 2. Length, width, and depth tolerance ±1/32 inch. Pfizer Inc Lake Forest, IL 60045 DO NOT SCALE TEMPLATEControl Level AQL's GLOBAL SUPPLYPALMER TRAY 11-15-173. For Rocky Mount,…
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 19August2021 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 …
Pfizer Documents (PHMPT/FDA)
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· 1 page
42598F Cross Tech–90501–Proof 1 Page M01 Fresenius Kabi USA, LLC P.O. 4700010512–Job No. 42598F 11/17/20–bw–InddCC15 Fonts: Helvetica Neue (A) Helvetica (A) Typesmiths Pi Font Interstate OCRBBLACK PMS182C DIE18AB Fresenius Kabi Lake Zurich, IL 60047 (01)20363323186023Sterile, Nonpyrogenic Preservative Free Discard unused portion. Each mL contains: Sodium chloride 9 mg; Water for Injection q.s. HCI and/or NaOH may have been added for pH adjustment. 0.3…
Pfizer Documents (PHMPT/FDA)
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· 1 page
21/64” 1/16” 5/16”11/64” 11/64” 2.15625”0.75” 1/64”Z18AV ZZ BLACK PMS182C DIE Cross Tech–90500–Proof 1 Page M01 Fresenius Kabi USA, LLC P.O. 4700010512–Job No. 401817G 11/17/20–bw–InddCC15 Fonts: Helvetica Neue (A) Helvetica (A) Typesmiths Pi Font Interstate OCRB LOT/EXP401817GNDC 63323 186 04 918602 Sodium Chloride Injection, USP 0.9% 2 mL Single Dose Vial FOR DRUG D LUENT USE Preservative Free Rx only Discard unused portion 3 63323-186-04 3Fresenius…
Pfizer Documents (PHMPT/FDA)
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· 1 page
Pfizer Inc Lake Forest, IL 60045 DO NOT SCALE TEMPLATEPlant Line(s): RM Lines 1A, 3, 14Dwg. No. DB5706085 AND 10mL LABEL HORIZONTAL ABLATION Reference: Control Level AQL'sDocument Owner: J. CottonVersion: V01Original Source:Dwg. No. TDG031200 Version: V03 GLOBAL SUPPLY2.5 x .875NOTES: 1. Commodity number to be black on white background. 2. Bar code: per market requirements. Human readables not required below bar code, except for Canadian market. Quiet zone not required.Font size 6 point OCRB…