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Monograph Soup: The ABCs & XYZs for OTCs on Formal Meetings with FDA

By Jacqueline R. Berman , Kathleen M. Sanzo , and Nikita S. Bhojani
// February 14, 2022
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles for meetings between FDA and meeting requestors.
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Topics: FDA, OTC
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