OTC Monograph Reform: Deemed Final Orders December 15, 2021

Virtual | Virtual

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• Date: December 15, 2021

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ABOUT THIS WEBINAR

This webinar will discuss:

• An overview of Over-the-Counter (OTC) Monograph Reform and will highlight Deemed Final Orders (DFOs).
• Certain final administrative orders (final orders), including for OTC drug monographs, that were deemed to be final orders by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which added a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• The process for making these final orders available.
• The new web portal, OTC Monographs@FDA, which:
  • Provides a resource for the public to view proposed, final, and interim final orders for OTC monograph drugs.
  • Facilitates the submission of comments and data from the public for proposed and interim final administrative orders, except if otherwise specified.

TOPICS COVERED

• Overview of OTC Monograph Reform
• OTC Drug Review before and after the CARES Act
• Status of existing OTC monograph drugs after CARES Act
• Types of deemed final orders
• OTC Monographs@FDA
• Withdrawal of certain regulations from the Code of Federal Regulations (CFR)

INTENDED AUDIENCE

• General public with an interest in nonprescription (also known as over-the-counter or OTC) drugs
• Regulatory affairs professionals involved in the development or marketing of OTC drugs
• Foreign regulators following the development or marketing of OTC drugs
• Consultants focused on OTC drug development or marketing
• Clinical research coordinators
• Importers of OTC drugs

FDA SPEAKER

Theresa Michele, MD
Director
Office of Nonprescription Drugs (ONPD) | CDER | FDA

FDA RESOURCES

• Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act
• FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation
• Final Administrative Orders for Over-the-Counter Monographs; Notice of Availability
• OTC Monographs@FDA