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US FDA OTC Monograph Meetings Guidance Should Be Familiar To Firms Using NDA Pathway, HBW Insight

Wednesday, February 23, 2022

While the Food and Drug Administration (FDA’s) draft guidance on meetings discussing potential over-the-counter (OTC) monograph order requests (OMOR) notes its applicable timeline will go into effect in October, partner Rebecca Dandeker tells HBW Insight she believes that the FDA would be open to meetings sooner. “I do think FDA would schedule a meeting before then (resources permitting), if the topic was important and applied to the industry as a whole, e.g. an OTC drug safety issue, or the initiation of new OMOR supported by one of the major trade associations,” Rebecca said.

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