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                Center for Biologics Evaluation and Research (CBER)

Center for Biologics Evaluation and Research (CBER)

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          Biologics Electronic Reading Room (eFOIA)Center for Biologics Evaluation and Research (CBER) Biologics Electronic Reading Room (eFOIA)
  
  	
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The Center for Biologics Evaluation and Research Freedom of Information Act (FOIA) Electronic Reading Room contains copies of CBER records (or links to other locations of CBER records) that we are making publicly available: (1) because the records are required to be published on the web by the Food, Drug and Cosmetic Act, (2) because they are “frequently requested” records under the FOIA (5 U.S.C. § 552(a)(2)(D)) or (3) proactively at our discretion. We will continue to add records to reflect public interest.

Compass
Information of Interest

Product Approval Information
 Product Safety/Availability, Compliance,
Surveillance, & Enforcement


Vaccine Adverse Events
 FDA Adverse Event Reporting System (FAERS)


CBER Advisory Committees
 Workshops, Meetings, & Conferences (Biologics)


FDA Forms
 FDA Newsroom


AstraZeneca COVID-19 Vaccine IND Related Records
	AstraZeneca COVID-19 Vaccine IND Related Records    
Pfizer-BioNTech Comirnaty COVID-19 Vaccine Related Records
	Biological License Application Records   Frequently Requested Comirnaty Records 



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Frequently Requested Records*

* - The Freedom of Information Act, 5 U.S.C. § 552(a)(2)(D) “copies of all records, regardless of form or format - (i) that have been released to any person under paragraph (3); and (ii)(I) that because of the nature of their subject matter, the agency determines have become or are likely to become the subject of subsequent requests for substantially the same records; or (II) that have been requested 3 or more times;”


Date Posted
			Records Description01/18/2024
			FDA Form 483 Millipore UK Ltd, Livingston, UK February 202011/20/2023
			FDA Form 483 Christine H Lee (Royal Jubilee Hospital) Victoria, British Columbia, Canada June 202208/11/2023
			FDA Form 483 Catalent Harmans, Maryland March 20237/14/2023
			Marion Gruber August 13, 2021 Email7/14/2023
			Phil Krause August 30, 2021 Email7/14/2023
			FDA Form 483 Paragon Gene Therapy - Catalent Harmans, Maryland June 202006/07/2023
			IHCTOA Letters04/11/2023
			FDA Form 483 Dendreon Corporation Morris Plains, NJ February 200704/11/2023
			FDA Form 483 Dendreon Corporation Morris Plains, NJ January 201008/15/2022
			Bavarian Nordic A/S Response Letter - August 12, 2022



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Additional Information

Contacts in the Center for Biologics Evaluation & Research (CBER)
	How to Make a FOIA Request
	FDA Electronic Reading Room

                                                                                  Content current as of:
      01/18/2024
              
              
Regulated Product(s)
		 BiologicsCenter for Biologics Evaluation and Research (CBER)

          
                        CBER Offices & Divisions
          CBER Vision & Mission
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          CBER Product Jurisdiction
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