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The Freedom of Information Act (FOIA) requires U.S. agencies to disclose many of their records. FDA's FOIA records usually aren't on the agency website; they're files from the desk drawers of reviewers, investigators, and other officials - and FOI Services has collected over 100,000 of these documents. Please note that under the Freedom of Information Act, the FDA is required to remove certain information from documents prior to releasing them. Some types of documents, such as 510(k)s and PMAs, are more heavily redacted than others. Most redactions used on these documents fall under the (b)(4) and (b)(5) exemptions of the Freedom of Information Act. Contact us at infoFOI@foiservices.com for more information.


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Document of the Week...

FDA Inspection and Approval Plans

Dated July 2021, this letter from the House of Representatives Committee on Energy and Commerce asks FDA 15 questions, all questioning the agency's efforts to mitigate the backlog of pharmaceutical manufacturing facility inspections and human drug applications to ensure continuing access to safe and effective therapeutics. The letter gives a clear look at the Congressional priorities likely to inform FDA's actions going forward.

Featured until September 28, 2021. Click here to download.