Overview

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in fiscal years 2018-2022; 2) Address the OTC/ Nonprescription Drugs Guidances as well as the recently issued draft guidance on “Formal Meetings Between FDA and Sponsors or Requestors of  Over-the-Counter Monograph Drugs”; 3) discuss the OTC [email protected] portal that provides a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.

Get Access

$99
  • +$100 for nonmembers

Internet Explorer and Microsoft Edge are not supported by the checkout process.

Please use Chrome, Firefox, or Safari.  If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.

Speakers

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

Virtual Learning FAQ

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.

 

On-demand content can be played back on most devices.

 

CLE credit is not currently available for pre-recorded sessions.

Related Content