FDAAA Leadership

Director

Mark A. Elengold

Mark A. Elengold

Mark A. Elengold is President of FDA Strategies LLC, which provides consulting services to FDA regulated industry and the financial community. He retired as the Deputy Director of the FDA's Center for Biologics Evaluation and Research, after thirty-four years of service. He is an expert and frequent speaker on regulatory and compliance activities, Good Manufacturing Practices (GMPs), and FDA application review procedures, including electronic submissions.

After receiving a B.A. from Queens College of the City University of New York in 1971, he served as an FDA investigator in the New York District Office and the White Plains Resident Post. Prior to joining CBER in December, 1988, he held various positions in the Center for Drug Evaluation and Research, the Bureau of Veterinary Medicine and the Office of the Commissioner.