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S037 - FDA Regulatory Science for Dermatologists

Sunday, March 3; 1:00 PM - 4:00 PM

Learning Objectives

Following this course, the attendee should be able to:

  • Identify the role of various parts of FDA in regulating dermatological products used in the care of our patients.
  • Describe some of the regulated product types, including recently approved or cleared products, as well as FDA's role in evaluating these products.
  • Apply knowledge gained to patient care and use of these products for improving disease outcomes and skin care.

Description

The U.S. Food and Drug Administration (FDA) regulates substantial portions of commerce, including foods, drugs, medical devices, cosmetics, tobacco, veterinary products. For the dermatologist, these include products we use on a day-to-day basis to care for our patients. This symposium is an opportunity for dermatologists to hear from some of the leaders at the FDA and the role of their organizations in regulating these products, ensuring their safety, effectiveness, and accessibility. Topics to include new, biologic, non-prescription, and generic drugs; product life cycle; medical devices including lasers and dermal fillers; cosmetics including tattoo inks and "cosmeceuticals".

Disclosures

  • Halachmi, Shlomit, MD: no financial relationships exist with commercial interests.
  • Katz, Linda, MD, MPH: no financial relationships exist with commercial interests.
  • Kopcha, Michael, PhD, RPh: no financial relationships exist with commercial interests.
  • Luke, Markham C., MD, PhD: no financial relationships exist with commercial interests.
  • Marcus, Kendall, MD: no financial relationships exist with commercial interests.
  • Marquart, Laura Nicole, MD: no financial relationships exist with commercial interests.
  • Michele, Theresa, MD: no financial relationships exist with commercial interests.
Schedule
Sunday, March 3
1:00 PM
Dr. Luke / Introduction to FDA
1:10 PM
Dr. Marcus / Drug Regulation and New Drugs
1:40 PM
Dr. Michele / Non-Prescription Drugs, Including Sunscreens
2:00 PM
Dr. Peters / Generic Drugs for Dermatology and Drug Access
2:20 PM
Kopcha / Drug Life Cycle and Drug Quality
2:40 PM
Dr. Marquart / Medical Device Regulation and New Devices
3:00 PM
Dr. Halachmi / Lasers and Energy Delivery Device Regulation
3:20 PM
Dr. Katz / Cosmetic Regulation, "Cosmeceuticals", and Tattoo Inks
3:50 PM
All faculty / Questions
Event Details
  • Date
    Sunday, March 3
  • Time
    1:00 PM - 4:00 PM
  • Location
    Room 102B
  • CME Credits
    3.00
  • Type
Directors/Co-Directors
  • Markham C. Luke, MD, PhD, FAAD
Speakers