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Recent draft guidance on scheduling FDA meetings to discuss potential OTC monograph order requests marks step in program overhaul authorized in 2020 legislation, but isn’t a signal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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Some would-be sponsors might opt against submitting OMORs because NDA process could offer more room for adjustments and a better chance for success. Absence of assurance in draft guidance of confidentiality for information sponsors share with FDA before submitting OMORs also could influence some to choose NDA process.
Firms making OTC monograph drugs won’t have to pay facility fees twice during FY2021, says Theresa Michele, FDA Office of Nonprescription Drugs director.
Authorization was a long time coming for FDA to reform OTC monograph program and streamline process to change formulations, indications or labeling for large majority of drugs available nonprescription. As program is overhauled, monograph updates may seem to be coming just as slowly.