Janice M. Hogan

Janice M. Hogan is a nationally recognized leader in FDA regulatory law, with over 25 years of experience advising medical technology companies on bringing innovative products to market. She represents clients in complex regulatory matters, focusing on high-tech medical devices across sectors such as diagnostics, women’s health, neurology, cardiovascular care, orthopedics, and combination products.

Janice’s background in engineering and healthcare uniquely positions her to understand both the technical and legal dimensions of FDA approval. She earned her Juris Doctor from Georgetown University Law Center, graduating magna cum laude and as a member of the Order of the Coif. She also holds a Bachelor of Science in Mechanical Engineering and Literature from the Massachusetts Institute of Technology.

Janice is known for guiding clients through “first-of-a-kind” FDA approvals and leveraging innovative regulatory strategies. Her expertise includes premarket submissions, advisory panel preparation, and the use of accelerated pathways like the de novo classification process.

Janice has played a lead role in landmark device approvals, including the first FDA/CMS parallel review, and approvals for devices treating conditions such as breast cancer, diabetes, obesity, and spinal disorders.

Janice’s client advocacy is informed by deep knowledge of FDA policy and a longstanding passion for scientific advancement. She helps companies design clinical trials, respond to agency feedback, and streamline review timelines. She also advises on compliance for in vitro diagnostics and drug/device combination products.

Recognized by publications such as Legal 500 US, LMG Life Sciences, and Who’s Who Legal, Janice M. Hogan continues to be a go-to advisor in the life sciences sector. Her work not only accelerates innovation but also supports safe and effective patient care by aligning groundbreaking medical technologies with FDA standards.

Law Office Affiliations

• Partner, Hogan Lovells US LLP
• Member, Pennsylvania Bar Association
• Member, District of Columbia Bar Association
• Member, American Bar Association
• Member, Maryland State Bar Association
• Member, National Health Lawyers Association

Licensed State

• Pennsylvania
• District of Columbia

Education

• Georgetown University Law Center
  Juris Doctor (JD)
• Massachusetts Institute of Technology
  Bachelor of Science (BS)

Awards & Badges