Janice Hogan is the Managing Partner of Hogan Lovells’ Philadelphia office and is Co-director of their FDA/medical device practice. Janice focuses her practice primarily on the representation of medical device, pharmaceutical, and biological product manufacturers before the US Food and Drug Administration. Janice is a biomedical engineer and focuses on regulatory counseling related to high-technology medical products.
She has authored articles regarding the medical device 510(k) review process, regulation of medical software, orphan drug regulation, and medical device product liability. She is currently authoring articles regarding the interface between FDA regulatory and reimbursement considerations in medical product clinical trial design. 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.