FDA and Medscape series for healthcare professionals The interview features Gerald Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, FDA Center for Drug Evaluation and Research FDA. Dr. Pan responds to questions from Medscape to detail the FDA’s outlook on postmarket drug safety. The article is part of a collaboration between FDA and[…]

The FDA has about 200 orphan drug designation requests that are pending review and that number has been steadily rising over the past five years. Recently, the FDA publicized its strategic plan to clear the bottleneck as part of its strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely[…]