• Provision Consulting Group

OTC Monograph Reform: OTC Sunscreen Drugs




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


SOURCE :

https://www.fda.gov/drugs/news-events-human-drugs/otc-monograph-reform-otc-sunscreen-drugs-12152021-12152021