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  1. 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

 
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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 Description
03/20/2024 August 19, 2020 Lucina BioSciences LLC Response Letter (TRG)
03/04/2024 CBER Laboratory Quality System Laboratory Procedure Test-Cal Method (TM) Document ID 000333
01/18/2024 FDA Form 483 Millipore UK Ltd, Livingston, UK February 2020
11/20/2023 FDA Form 483 Christine H Lee (Royal Jubilee Hospital) Victoria, British Columbia, Canada June 2022
08/11/2023 FDA Form 483 Catalent Harmans, Maryland March 2023
7/14/2023 Marion Gruber August 13, 2021 Email
7/14/2023 Phil Krause August 30, 2021 Email
7/14/2023 FDA Form 483 Paragon Gene Therapy - Catalent Harmans, Maryland June 2020
06/07/2023 IHCTOA Letters
04/11/2023 FDA Form 483 Dendreon Corporation Morris Plains, NJ February 2007
04/11/2023 FDA Form 483 Dendreon Corporation Morris Plains, NJ January 2010
08/15/2022 Bavarian Nordic A/S Response Letter - August 12, 2022
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Additional Information

 
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