U070 FDA for Dermatologists
DESCRIPTION
Open admission to eligible categories, no tuition or ticket
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 dermatology product development from an FDA perspective.
LEARNING OBJECTIVES
Identify the various parts of FDA, i.e. at each of the Centers, that have significant impact on dermatologists and dermatology
Discuss the role of the dermatologist/reviewers and managers who are dermatologists at FDA in regulating products
Summarize some of the most recent changes in FDA regulation of drugs, cosmetics, and medical devices, drug access (including generic drug initiatives) and their impact on the dermatologist
SCHEDULE
11:30 PM
FDA Background and Updates
12:15 AM
Questions and Discussion
SPEAKERS
Linda Katz, MD, MPH
Markham C. Luke, MD, PhD, FAAD
HANDOUTS
SPEAKER DISCLOSURES
Linda Katz, MD, MPH
No financial relationships exist with ineligible companies.
Markham C. Luke, MD, PhD, FAAD
No financial relationships exist with ineligible companies.