U020 FDA for Dermatologists
DESCRIPTION
Biologic drugs and biosimilar drug products will be the main focus of our 2026 FDA Forum: FDA for Dermatologists. This session is designed to be an interactive session to dialogue regarding FDA regulation of dermatology-relevant products, to discuss some of the latest initiatives that affect access, and to understand how to navigate certain aspects of FDA as pertinent to the practicing dermatologist. Medical dermatology products have lifecycles, from product inception, design, development, approval and marketing. We plan to discuss our insight into some of the latest in biologic dermatology product development from an FDA perspective.
LEARNING OBJECTIVES
Identify the organization of FDA and its various Centers - CDER, CBER, CDRH - that have significant impact on dermatology with regard to regulating drugs (including biosimilars), devices, and cosmetics.
Summarize how our scientific understanding of the skin and therapeutic products impact regulation.
Describe how biosimilar drugs for dermatology are reviewed by FDA and understand what can be expected regarding safety and therapeutic effectiveness.
SCHEDULE
3:30 PM
Biosimilars and Generic Drugs for Dermatology
DIRECTOR
Markham C. Luke, MD, PhD, FAAD
SPEAKERS
Cristina Ausin
Sarah Ikenberry
DISCLOSURES
Cristina Ausin
No financial relationships exist with ineligible companies.
Sarah Ikenberry
No financial relationships exist with ineligible companies.
Markham C. Luke, MD, PhD, FAAD
No financial relationships exist with ineligible companies.