Over-the-Counter Drugs Monograph Reform - How’s it Going?

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Recorded May 5, 2022 | On-Demand Webinar

The CARES Act was implemented in 2020 and has modernized the regulation of the OTC Drugs Monograph to improve efficiency, timeliness, and predictability in the process. This webinar will provide an overview of how the CARES Act has reformed the OTC drug review process and updates on what the FDA has done this far regarding implementation. It will also explore 1) Over-The-Counter Monograph Drug User Fee Program (OMUFA) and where the FDA is in meeting statutory deadlines as well as their performance goals and procedures in the fiscal years 2018-2022; 2) Address the OTC/ Nonprescription Drugs Guidances as well as the recently issued draft guidance on “Formal Meetings Between FDA and Sponsors or Requestor of Over-the-Counter Monograph Drugs”; 3) discuss the OTC [email protected] portal that provides a resource for the public to view proposed, final, and interim final orders for OTC drugs monograph; 4) how OTC Monograph Reform can advance efforts to address healthcare disparities and; 5) what industry can expect over the next 12 months.

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