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Recent draft guidance on scheduling FDA meetings to discuss potential OTC monograph order requests marks step in program overhaul authorized in 2020 legislation, but isn’t a signal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.
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Draft guidance adds “formal dispute resolution” to other terms becoming common in OTC drug sector since agency began overhaul of monograph drug program authorized in 2020. Others are OMOR, for OTC monograph order request, and OMUFA, for user fee program also authorized.
Submitting other OTC monograph program communications through CDER's NextGen Portal, including proposals to add formulations or indications to a monograph, will have to wait.
Submissions go to one of two addresses: OMORs, for changes or additions to monograph formulations and indications, go to the CDER NextGen Portal, and data, information and public comments on proposed or interim final orders go to OTC Monographs@FDA.