Changes in federal regulations that affect clinical dermatology will be the focus of “FDA Hot Topics: The Evolving Regulatory Landscape,” a new session that will be offered from 1 to 3 p.m. Monday, March 7, in Room 145A.
The session will be directed by Jill A. Lindstrom, MD, clinical team leader, division of dermatology and dental products, Center for Drug Evaluation and Research at the FDA; and co-directed by Markham C. Luke, MD, PhD, deputy office director, office of device evaluation, Center for Devices and Radiological Health at the FDA. Additional guest speakers invited from the FDA are:
- Linda Katz, MD, MPH, director, office of cosmetics and colors, Center for Food Safety and Applied Nutrition
- Theresa Michele, MD, division director, division of non-prescription drug products, Center for Drug Evaluation and Research
- Jane Axelrad, associate director for policy, Center for Drug Evaluation and Research
As dermatologists know, the FDA regulates many products that intersect with dermatology practice — including drugs, devices, biologic products, and cosmetics. This session will incorporate FDA experts — including dermatologists — who will provide updates on FDA regulations that impact clinical dermatology, such as the marketing of cosmetic products, the compounding of human drug products, and the approval of new sunscreen ingredients, drugs, and medical devices. The FDA experts will also address changes in the regulation of indoor tanning.
At the end of the session, attendees will have a better understanding of the regulatory process, and should be able to identify challenges related to FDA-regulated products that are used by the practicing community. Attendees should also be able to describe the differences in regulations between drugs and cosmetics, and evaluate the effectiveness and safety data of sunscreen and other products.
This session will offer 2 CME credits, and is open admission to all eligible categories; no ticket or tuition is required to attend.