NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Andrea Leonard-Segal, MD, FACR

Practice Area Focus

  • Drugs
  • OTC NDA & Monograph
  • Combination Products
  • Generics

Biography

Dr. Andrea Leonard-Segal joined NDA Partners as an Expert Consultant in 2016 after a 15 year career at the FDA where she served as the Director of the Division of Nonprescription Clinical Evaluation (DNCE). The division was responsible for the review and evaluation of over-the-counter (OTC) drug research and applications including safety, effectiveness, consumer-based social science data, and labeling for OTC drug submissions. Since the assortment of OTC drugs is so broad, she collaborated with most divisions within CDER and occasionally with CDRH and CTP. She also represented the FDA at meetings with industry, the media, international drug agencies, and the public.

Dr. Leonard-Segal worked on monograph ingredient efficacy and safety, rulemaking, and compliance issues related to OTC drug products. Prior to becoming Division Director, she served as the Acting Director, Clinical Team Leader, and Medical Officer in the OTC drug division.

Dr. Leonard-Segal is a rheumatologist who continues to treat patients and teach medical students and residents. Prior to joining the FDA, she served as a Senior Physician in the Division of Rheumatology at the Washington DC Veterans Administration Medical Center, where she saw patients, taught Georgetown University Rheumatology fellows, conducted clinical research, and reviewed protocols for the Institutional Review Board.

Dr. Leonard-Segal graduated from the George Washington University School of Medicine with distinction and was inducted into the Alpha Omega Alpha Honorary Medical Society.