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'Milestone' Discussions With US FDA On OTC Monograph Proposals Limited To One Meeting

With Monograph Order Request Meetings, Agency Will Serve Unpaid User Fee Notices

 
• By Malcolm Spicer

Recent draft guidance on scheduling and conducting meetings with FDA supported by OTC monograph user fees largely tracks with agency’s guidance for meetings supported by other user fee programs, such as PDUFA.

• Source: Alamy

A Food and Drug Administration draft guidance sheds light on scheduling meetings to discuss potential OTC monograph order requests (OMORs), including explaining that some firms will be in the dark due to unpaid fees imposed in the agency’s overhaul of the program. 

The draft published January on scheduling and conducting meetings with the FDA supported by OTC monograph user fees also...

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