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Slides

This webinar will provide an overview of nonprescription drugs, Over-the-Counter (OTC) Monograph Reform, and how FDA identifies and evaluates safety issues.  The webinar will also explain the procedure for FDA-initiated administrative orders to address safety issues and how the public can participate in the administrative order process.

TOPICS 

• Nonprescription drugs and Over-the-Counter (OTC) Monograph Reform
• FDA’s identification, evaluation and response to safety issues.  
• Procedure and timeline for FDA-initiated administrative orders to address safety issues
• OTC Monographs@FDA and comment submission

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

LEARNING OBJECTIVES

• Provide an overview of nonprescription drugs 
• Provide an overview of Over-the-Counter (OTC) Monograph Reform
• Discuss how FDA identifies, evaluates, and responds to safety issues 
• Provide an overview of FDA-initiated administrative orders to address safety issues
• Provide an overview of OTC Monographs@FDA and comment submission

FDA SPEAKERS

Valerie Pratt, MD
Deputy Director for Safety
Division of Nonprescription Drugs I | Office of Nonprescription Drugs | CDER | FDA

Evelyn Mentari, MD, MS
Acting Deputy Director for Safety
Division of Nonprescription Drugs II | Office of Nonprescription Drugs | CDER | FDA

FDA RESOURCES

• Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act
• FDA STATEMENT - FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation