Sponsorships and Speaking Engagements
FDLI Introduction to Medical Device Law and Regulation
17-19 November 2020
PartnerPhiladelphia, Washington, D.C.
Email janice.hogan@hoganlovells.com
Phone +1 267 675 4611 (Philadelphia) +1 202 637 5600 (Washington, D.C.)
Fax +1 267 675 4601 (Philadelphia) +1 202 637 5910 (Washington, D.C.)
LanguagesEnglish
Practice groupGlobal Regulatory
Janice Hogan has been involved in medical technology for over 25 years. From her engineering training at the Massachusetts Institute of Technology to work in the pharmaceutical industry, to her current practice representing medical device companies before the U.S. Food and Drug Administration (FDA), Janice has focused her career on the intersection of technology, regulation, and health care.
Widely recognized as a leader in FDA regulation of devices, Janice is co-director of the FDA Medical Device practice. She leverages her technical background to help companies with cutting-edge technologies navigate and optimize the FDA approval process.
Janice focuses on FDA regulation of high-tech products in women's health, diagnostics, neurology, cardiovascular, and orthopedics. She has assisted companies to obtain "first-of-a-kind" FDA approvals, providing guidance on regulatory strategy, clinical study design, advisory panel proceedings, and tools to expedite product approval.
Janice brings her lifelong passion for science and innovation to bear in her client advocacy. Through her extensive experience representing companies in a wide range of FDA interactions, Janice has been at the forefront of several of the most innovative medical device approvals, including the first successful FDA/Centers for Medicare and Medicaid Services parallel review project, as well as first-in-class approvals for devices used in treatment of breast cancer, diabetes management, obesity, spinal surgery, and neurology, as well as a variety of drug/device combination products. Janice also has substantial experience using newer FDA approval mechanisms such as the de novo process to reduce review time and bring products to market earlier, accelerating patient access.
Healthcare: Life Sciences
Legal 500 US
Most Highly Regarded Firm for Life Sciences 2018
Who's Who Legal
Life Sciences Star
LMG Life Sciences
Who's Who Legal Life Sciences: Regulatory Lawyers
Who's Who Legal
Regulatory: Medical Devices
PLC Life Sciences Cross-border Handbook
Education
J.D., Georgetown University Law Center, magna cum laude, Order of the Coif, 1995
B.S. Mechanical Engineering and Literature, Massachusetts Institute of Technology, 1988
Memberships
Member, American Bar Association
Member, Maryland State Bar Association
Member, National Health Lawyers Association
Bar admissions and qualifications
Pennsylvania
District of Columbia
Sponsorships and Speaking Engagements
17-19 November 2020
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