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

Janet B. Arrowsmith, MD

Practice Area Focus

  • Development Strategy
  • Regulatory Strategy
  • Medical Devices
  • Drugs & Biologics
  • Epidemiology
  • Postmarket Surveillance
  • Antivirals/HIV

Biography

Dr. Arrowsmith joined NDA Partners as a Premier Expert consultant in 2014. She is board-certified in internal medicine and an epidemiologist trained at the federal Centers for Disease Control (CDC). She has extensive experience in pharmaco-epidemiology at the US Food & Drug Administration (FDA) and has served both as a member of the Special Emphasis Panel of the National Institute of Allergy & Infectious Disease (NIAID) and a consultant to the National Institute of Drug Abuse (NIDA). During her 11 year career at the FDA, Dr. Arrowsmith was selected as Acting Director, Office of Surveillance and Biometrics in CDRH; Medical Review Officer in both the Division of Blood Applications (CBER) and the Division of Anti-viral Drug Products (CDER); and as Deputy Director, Office of AIDS and Special Health Concerns, Office of the Commissioner.

Dr. Arrowsmith served as a Commissioned Officer in the US Public Health Service where she achieved the Navy rank of Captain. She has published numerous articles in peer reviewed medical literature, authored or co-authored several book chapters on postmarket surveillance, and spoken before numerous national medical and professional organizations on medical product regulation. Dr. Arrowsmith in an elected fellow of both the American College of Physicians and the American College of Epidemiology