Virtual | Virtual
Event Title
OTC Monograph Reform: OTC Sunscreen Drugs
December 15, 2021
Event Title
OTC Monograph Reform: OTC Sunscreen Drugs
- Date:
- December 15, 2021
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ABOUT THIS WEBINAR
On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs. FDA posted the deemed final order (DFO) for sunscreens which sets the current requirements for marketing OTC sunscreen products. FDA also posted the proposed order for sunscreens to amend and revise this deemed final order for OTC sunscreens products.
This webinar will:
- Discuss the DFO for OTC sunscreen drugs and proposed order for OTC sunscreen drugs
- Compare and contrast the major provisions of the DFO for OTC sunscreen drugs and the proposed order for OTC sunscreen drug
TOPICS COVERED
- Overview of OTC sunscreen drugs
- Relevant regulatory history for OTC sunscreen drugs
- Overview of OTC Monograph Reform
- DFO for OTC sunscreen drugs
- Proposed Order for OTC sunscreen drugs
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
Steven Adah, PhD.
Associate Director of Monographs
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
- Deemed Final Order for OTC Sunscreens - Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
- Proposed Order for OTC Sunscreens - Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
- OTC Monographs @ FDA
- An update on sunscreen requirements: The deemed final order and the proposed order