---

---

---

Visit CDER Small Business and Industry Assistance Page

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

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

• To optimize your webinar experience, use Chrome when viewing AdobeConnect in a browser.
• Please contact info@sbiaevents.com for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support.
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.