Janice Hogan

Janice Hogan is the managing partner of Hogan Lovells' Philadelphia office and is co-director of its FDA/Medical Device practice. Janice focuses her practice primarily on the representation of medical device, pharmaceutical, and biological product manufacturers before the U.S. Food and Drug Administration (FDA).

A biomedical engineer, she held positions in marketing/marketing research for a major pharmaceutical manufacturer prior to becoming an attorney. She has authored articles regarding the medical device 510(k) review process, regulation of medical software, orphan drug regulation, and medical device products liability, and a chapter of a recent textbook, Promotion of Biomedical Products (FDLI 2006).

Janice has served as an adjunct professor at the University of the Sciences in Philadelphia and as a guest lecturer at the Wharton School, Drexel University, and Stanford University on the development and regulation of medical products. She is also a frequent lecturer at FDA regulatory law symposia and conferences on topics related to premarket approval of medical products, combination products regulation, and product development, and has served on the faculty of FDA's staff college training for new review staff.

Questions to the author may be directed to Janice.hogan@hoganlovells.com.