On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136) was signed into law. In addition to aiding the COVID-19 response efforts, the CARES Act amended the FD&C Act to include statutory provisions that (1) reform and modernize the way over-the-counter (OTC) monograph drug products are regulated in the United States and (2) authorize the U.S. Food and Drug Administration (FDA or Agency) to assess and collect user fees from qualifying manufacturers of OTC monograph drug products and submitters of OTC monograph order requests.
OMUFA I (FY 2021 to FY 2025)
OMUFA supports FDA's important OTC monograph drug activities and ultimately helps provide safe, effective, and innovative OTC monograph drug product options for the general public.
Annual performance reports are prepared by FDA's Office of Planning, Evaluation and Risk Management in collaboration with the Center for Drug Evaluation and Research.
For additional information on these reports, please contact:
Office of Planning, Evaluation and Risk Management
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002