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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

 
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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
07/09/2024 FDA EIR Aldevron, LLC Fargo, ND November 2021
06/18/2024 FDA Form 483 FUJINOMIYA FACTORY OF TERUMO CORP Fujinomiya, Japan May 2023
04/25/2024 FDA Form 483 Fenwal International Inc. Bajos De Haina, Dominican Republic April 2023
04/25/2024 FDA Form 483 Novo Nordisk Kalundborg, Denmark April-May 2023
04/25/2024 FDA Form 483 Krystal Biotech Inc, Pittsburgh, PA November 11-16, 2022
04/16/2024 FDA Form 483 BioMarin Pharmaceuticals, Inc., Novato, CA  December 2022
04/16/2024 FDA Form 483 Bristol Myers Squibb, Devens, MA May 2023
04/16/2024 FDA Form 483 Samsung Biologics Co. Yeonsu-gu, Republic of Korea Feb. 2023
04/01/2024 BLA 125062-674 June 28, 2021 Pharmacovigilance Plan Review Memo
04/01/2024 BLA 125062-674 June 22, 2021 Memo Committee Memo Statistical Review
04/01/2024 BLA 125062-674 June 22,2021 Memo Other Final Draft Labeling
04/01/2024 BLA 125062-674 June 23, 2021 Memo Committee Memo CMC
04/01/2024 BLA 125062-674 June 29, 2021 Memo Committee Memo Preclinical Pharm-Tox Review
04/01/2024 BLA 125062-674 July 14, 2021 Memo Committee Memo BIMO Review Memo
04/01/2024 BLA 125062-674 July 15, 2021 Memo Committee Memo Clinical
3/20/2024 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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