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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: FDARA Section 902 Annual Report on Inspections

 

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On August 18, 2017, the FDA Reauthorization Act (FDARA) (Public Law 115-52) was signed into law. FDARA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to revise and extend the user fee programs for human drugs, biologics, generic drugs, medical devices, and biosimilar biological products.

FDARA Section 902 required FDA to post calendar year information related to inspections of facilities necessary for the approval of specified human drugs and medical devices. On December 29, 2022, the Food and Drug Omnibus Reform Act of 2022 (FDORA) (Public Law 117-328) was signed into law. FDORA amended the reporting requirements of FDARA Section 902 and modified the reporting period from calendar year to fiscal year starting in 2023.

Annual performance reports are prepared by FDA’s Performance Management Staff (PMS) in collaboration with the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Office of Inspections and Investigations.

 

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