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'Milestone' Discussions with US FDA on OTC Monograph Proposals Limited To One Meeting, HBW Insight

Wednesday, February 23, 2022

Recent draft guidance from the Food and Drug Administration (FDA) sheds light on scheduling meetings to discuss potential over-the-counter (OTC) monograph order requests (OMORs). 

A Food and Drug Administration FDA draft guidance sheds light on scheduling meetings to discuss potential OMORs, including explaining that some firms will be in the dark due to unpaid fees imposed in the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

An HBW Insight article reports that some stakeholders may have questions about the Office of Nonprescription Drugs in FDA’s Center for Drug Evaluation and Research, stating that Y Type meetings are limited to one per OMOR. Partner Rebecca Dandeker pointed out that meetings under the agency’s other drug user fee-supported programs aren't limited to one per new drug application (NDA).

"One interesting policy decision is that a requestor may have only one Type Y meeting per OMOR development program or Monograph conditions-of-use update. Although this is a practical way to preserve FDA's resources, it is very different from the NDA meeting procedures, which permit and even expect multiple meetings with FDA prior to submission of an NDA," Rebecca stated.

Read the full HBW Insight article >>
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