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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.