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Visit CDER Small Business and Industry Assistance Page

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

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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