The Food and Drug Administration’s overhauled OTC monograph program resembles the agency’s process for prescription drug applications not only for adding ingredients and indications but also for scheduling meetings application sponsors will have with agency officials.
US FDA OTC Monograph Meetings Guidance Should Be Familiar To Firms Using NDA Pathway
Recent draft guidance on scheduling FDA meetings to discuss potential OTC monograph order requests marks step in program overhaul authorized in 2020 legislation, but isn’t a signal for manufacturers, other industry stakeholders to expect meetings soon.

More from Regulation
More from Policy & Regulation
A round-up of the latest industry moves in Europe: Pharma Deutschland elects board of new Brussels operation; MHRA's new CEO gets to work; Futura names non-executive director.
“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. “If we reauthorize it, will it continue?” Texas representative Lizzie Fletcher asks of OMUFA.