Stakeholders Raise Concerns With OMUFA II Safety Reporting Process

FDA detailed plans to make the over-the-counter monograph process more efficient at its second and final public meeting Wednesday (Nov. 20) on the first reauthorization of the OTC monograph user fee amendments (OMUFA), but some stakeholders said they wanted to see improvements in how safety issues are reported. The current legislative authority for OMUFA expires in September 2025 and Congress will need to reauthorize the program for the first time. In a process similar to other user fee programs, FDA...