AAD
  • Registration
  • Daily Coverage
  • Industry Highlights
  • Product Samples
  • Small Exhibit Spotlight
  • Program
Topics
  • Daily Coverage
  • Industry Highlights
  • Product Samples
  • Small Exhibit Spotlight
  • Program
Resources
  • Registration
Facebook iconInstagram iconTwitter icon
Feb 14, 2022

New session examines FDA hurdles

Session dissects the regulatory process.


Markham Luke, MD, PhD, FAAD.
Markham Luke, MD, PhD, FAAD.

U065 – FDA for Dermatologists

Date: Sunday | March 27

Time: 4:30 – 5:30 p.m.

By the time dermatologists reach for the prescription pad, the FDA has already invested years into product research and development. As such, dermatologists should understand the regulatory process behind the FDA’s pre-market evaluation of medications and devices to have an appreciation for the products they use.

Understanding FDA regulations and labeling is all a part of the session, U065 – FDA for Dermatologists. Session presenter Markham Luke, MD, PhD, FAAD, the FDA’s director of Therapeutic Performance of Generic Drugs, underscored the need for dermatologists to keep current with FDA’s guidelines.

“It is important for dermatologists to be aware of FDA-approved labeling on drugs and instructions for use of devices prior to using them,” he said. “It is equally important for dermatologists to be aware of how the products they prescribe are regulated, from approval to post-market surveillance.”

One area the FDA’s Office of Generic Drugs is currently investigating is topical drug bioequivalence — assessing the possible biologic equivalence of different proprietary drugs. Dr. Luke said this is a great example of FDA’s research engagement in the science of dermato-pharmacology.

“One key area is the potential for an in-vitro approach to bioequivalence evaluations for certain topical drugs,” he said. “Such evaluations potentially allow for more precise determinations of bioequivalence than comparative clinical endpoint bioequivalence studies that have been recommended in the past.”

During the session, Dr. Luke will explore the regulatory science behind these drugs as well as recent advances. Additionally, he will detail how the FDA monitors drug products at all levels of the supply chain, and how dermatologists can contribute to that effort.

“Drugs and medical devices may have unexpected safety issues that are identified from time to time,” he said. “It is important for dermatologists to know how to alert the FDA should that be the case. In addition, certain products have specific issues such as safety mitigation strategies for their use. Dermatologists should know some of the pathways to alert the FDA for issues related to access or safety.”

Those pathways include the use of MedWatch, the FDA’s medical product safety reporting program for health professionals, patients, and consumers. Beyond partnering with the FDA in an advisory capacity, Dr. Luke said many dermatologists assume roles in the FDA in the review of new drugs and biologics, generic drugs, and new devices.

Visit AAD DermWorld Meeting News Central for more articles.

Interesting Stories
DermWorld | Jan: A Juggling Act
Presented by AAD
DermWorld | Jan: A Juggling Act
What makes a biosimilar and an Interchangeable biosimilar different?
Presented by Boehringer Ingelheim
What makes a biosimilar and an Interchangeable biosimilar different?
More in Daily Coverage
Left to right: Taylor Gray, DO, FAAD, and Morgan Brianne Murphrey, MD, MS.
AAD 2023 Annual Meeting
Set yourself up for success
Feb 03, 2023
Img 3020
AAD 2023 Annual Meeting
Management pearls for your practice!
Feb 03, 2023
Getty Images 619236488
AAD 2023 Annual Meeting
These AAD sessions can help you lead the way
Feb 03, 2023
Ben Jacob Friedman, MD, FAAD, and Bridget Shields, MD, FAAD, are leading two, new debate sessions.
AAD 2023 Annual Meeting
We need to talk
Feb 03, 2023
Img 2887
AAD 2023 Annual Meeting
The hottest sessions are back for 2023!
Feb 03, 2023
Img 2929
AAD 2023 Annual Meeting
Exciting industry programs return this year in New Orleans!
Feb 03, 2023
Img 3019
AAD 2023 Annual Meeting
Finish strong. Attend these Tuesday symposiums
Jan 13, 2023
Safi Bahcall, AAD 2023 Annual Meeting Keynote Speaker
AAD 2023 Annual Meeting
Meet keynote speaker Safi Bahcall
Jan 13, 2023
Getty Images 1143723457
AAD 2023 Annual Meeting
Roulez into NOLA for the latest AAD Annual Meeting
Jan 13, 2023
Picture1
AAD 2023 Annual Meeting
Start your session search!
Jan 13, 2023
Venue Photo
AAD 2023 Annual Meeting
Beware of fraudulent meeting registration sites!
Jan 13, 2023
Global Ed Photo
AAD 2023 Annual Meeting
Come a day early for Global Education Day
Jan 13, 2023
AAD
Facebook iconInstagram iconTwitter icon
© Ascend Media All rights reserved. DermWorld Meeting News Central is a publication of the American Academy of Dermatology.