Janice Hogan is the Managing Partner of Hogan Lovells’ Philadelphia office and is Co-Director of our 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).
Janice is a biomedical engineer and focuses on regulatory counseling related to high technology medical products. Prior to becoming an attorney, she held positions in marketing/marketing research for a major pharmaceutical manufacturer. She has authored articles regarding the medical device 510(k) review process, regulation of medical software, orphan drug regulation and medical device products liability. She is currently authoring articles regarding the use of finite element analysis and other engineering modeling methods in FDA submissions, as well as the interface between FDA regulatory and reimbursement considerations in the design of medical product clinical trials. She has authored a chapter of a recent textbook, Promotion of Biomedical Products (FDLI 2006) and is authoring a chapter of a forthcoming textbook on the regulation of orthopedic implants.
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.
Janice formerly served as a law clerk to The Honorable Irma S. Raker of the Maryland Court of Appeals.