Biologics Electronic Reading Room (eFOIA)
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.
Information of Interest
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 |
---|---|
03/04/2024 | 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 |