Jonathan Jarow is an expert on the FDA’s regulation of innovative pharmaceutical products and medical devices. A board-certified physician, he is the founder and CEO of FDA Solutions LLC, a consulting firm serving FDA-regulated companies.
Prior to founding FDA Solutions, Dr. Jarow spent almost ten years at the FDA in various leadership roles. He has been a primary clinical reviewer of investigational new drugs (INDs), new drug applications (NDAs), Biologics License Applications (BLAs), and Premarket Approvals (PMAs). In addition, he has led multidisciplinary professional staff in the development of high-priority FDA policies and programs. Dr. Jarow’s policy and implementation experience includes expedited drug development and approval pathways, drug recalls, rare diseases, human factor studies, software as a medical device, drug pricing, product labeling, and advertising and promotion.
Before joining the FDA, Dr. Jarow was Professor of Urology, Pathology, Radiology, and Biochemistry & Molecular Biology at Johns Hopkins University School of Medicine. He also served as clinical investigator for industry-sponsored clinical trials. Dr. Jarow’s clinical practice at Johns Hopkins focused on traditional and robotic surgery. Previously, he was associate professor of urology and obstetrics/gynecology at Wake Forest University’s Bowman Gray School of Medicine.
Dr. Jarow is the author of more than one hundred peer-reviewed publications. His research has appeared in the Journal of the American Medical Association (JAMA), the New England Journal of Medicine, and Nature Reviews Drug Discovery, among others.
Dr. Jarow has served as an expert witness and has extensive deposition and trial experience, including in federal, state, and international arbitration courts.
