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.

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