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 thus 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 its performance goals and procedures in fiscal years 2018-2022; 2) Address the OTC/ Nonprescription Drugs Guidances as well as the recently issued draft guidance on “Formal Meetings Between FDA and Sponsors or Requestors of  Over-the-Counter Monograph Drugs”; 3) discuss the OTC Monographs@FDA portal that provides a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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Ann M. Begley, Partner, Wiley LLP
Elizabeth Guo, Associate Chief Counsel, Office of Chief Counsel, FDA
David C. Spangler, Senior Vice President, Policy, and General Counsel, Consumer Healthcare Products Association (CHPA), and Member, FDLI Board of Directors
Moderated by Jessica P. O’ Connell, Partner, Covington & Burling LLP

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