The FDA is hosting a public meeting on September 28, 2023, to discuss the development of reauthorization recommendations for the Over-the-Counter Monograph Drug User Fee Program (OMUFA II). The public meeting will include an overview of the OMUFA reauthorization process and presentations from regulated industry and other interested parties.
A full list of topics to be discussed will be detailed in the forthcoming agenda and will be posted on the meeting webpage.
People who are interested in participating in this meeting should register and review the instructions at the meeting webpage. If interested parties cannot attend the meeting, they can still provide input through the public docket when the Federal Register notice publishes.
FDA will consider the information and feedback received at the public meeting and through the public docket before negotiations officially start. After negotiations end, the agency plans to hold a second public meeting to keep the public informed.
Visit OTC Monographs @ FDA for additional information about OTC monographs.
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