Date:
December 15, 2021
Time:
3:00 PM - 4:00 PM ET
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
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