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Virtual | Virtual

Event Title
OTC Monograph Reform: Deemed Final Orders
December 15, 2021

December 15, 2021

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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.


  • 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)


  • 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


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



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