AAD
  • Registration
  • Daily Coverage
  • Industry Highlights
  • Product Samples
  • Program
  • Photo Gallery
Topics
  • Daily Coverage
  • Industry Highlights
  • Product Samples
  • Program
  • Photo Gallery
Resources
  • Registration
Facebook iconInstagram iconTwitter X 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
<i>DermWorld</i> July | Supplements and the skin
Presented by AAD
DermWorld July | Supplements and the skin
<i>DermWorld</i> June | Problematic in Pregnancy
Presented by AAD
DermWorld June | Problematic in Pregnancy
Quick tips for navigating the Innovation Academy
Presented by Dermavant
Quick tips for navigating the Innovation Academy
Unveiling the potential of the aryl hydrocarbon receptor
Presented by Dermavant
Unveiling the potential of the aryl hydrocarbon receptor
More in Daily Coverage
2 J6 A5263
Innovation Academy 2023
Successful 2023 Innovation Academy closes the gap on learning
Aug 18, 2023
2022 03 21 12 26 25 6238b55bf2d38 640e3f2761020
Innovation Academy 2023
2023 Innovation Academy: Claim CME
Aug 18, 2023
Kenneth J. Tomecki, MD, FAAD
Innovation Academy 2023
Science backs vitamin treatment for pediatric eczema
Aug 18, 2023
Keyvan Nouri, MD, MBA, FAAD
Innovation Academy 2023
Business as usual?
Aug 18, 2023
M. Laurin Council, MD, MBA, FAAD
Innovation Academy 2023
On the rare side of skin cancer
Aug 18, 2023
Carolyn Goh, MD, FAAD
Innovation Academy 2023
More than a head of hair
Aug 18, 2023
Gil Yosipovitch, MD, FAAD
Innovation Academy 2023
Don’t ignore the power and persistence of itch
Aug 18, 2023
Jennifer Hsiao, MD, FAAD
Innovation Academy 2023
Hidradenitis suppurativa: Clinical pearls from your peers
Aug 12, 2023
Left to right: Charlene Lam, MD, MPH, FAAD, and Alexandra Flamm, MD, FAAD
Innovation Academy 2023
Learn to lead — and adapt
Aug 12, 2023
Barbara Ann Gilchrest, MD, FAAD
Innovation Academy 2023
Better sunscreen education applies to all
Aug 12, 2023
Ginette Okoye, MD, FAAD
Innovation Academy 2023
Stepping up for the underserved
Aug 12, 2023
Alice B. Gottlieb, MD, PhD, FAAD
Innovation Academy 2023
What we’ve learned about psoriatic arthritis
Aug 12, 2023
AAD
Facebook iconInstagram iconTwitter X icon
© Ascend Media All rights reserved. DermWorld Meeting News Central is a publication of the American Academy of Dermatology.