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Recent draft guidance on scheduling FDA meetings to discuss potential OTC monograph order requests marks step in program overhaul authorized in 2020 legislation, but isn’t a signal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.

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.

Still, while a recent draft guidance on scheduling meetings with agency officials to discuss potential OTC monograph order requests...