Gail H. Javitt

Gail H. Javitt


Hyman, Phelps & McNamara, P.C.

Recognized since 2025

Washington, District of Columbia

Practice Areas

FDA Law

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Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage. She also has significant experience advising clinical laboratories on FDA and CLIA requirements for laboratory developed tests.

Ms. Javitt’s experience prior to joining Hyman, Phelps & McNamara includes serving as a partner in a leading Washington, DC health law practice and as a law and policy director at the Genetics and Public Policy Center, part of Johns Hopkins University. At the Center, she was responsible for developing policy options to guide the development and use of reproductive and other genetic technologies. Earlier in her legal career, Ms. Javitt clerked for the Honorable Gary Taylor of the U.S. District Court for the Central District of California.

In addition, Ms. Javitt has published and spoken widely on issues at the intersection of law, science, ethics and policy, including FDA regulation of genetic testing, precision medicine, and next-generation sequencing. Her academic experience has included serving as a faculty member at the Berman Institute of Bioethics at Johns Hopkins University and as an adjunct professor at the Georgetown University Law Center, American University’s Washington College of Law, and the University of Maryland School of Law. She was previously a Greenwall Fellow in Bioethics and Health Policy, a collaborative effort between Johns Hopkins University and Georgetown University

Location
  • 700 Thirteenth Street, NW, Suite 1200
    Washington, DC 20005
Education
  • Columbia University, B.A.
  • Harvard University, J.D.
Bar Admissions
  • Maryland, Maryland State Bar Association
  • District of Columbia, The District of Columbia Bar

Hyman, Phelps & McNamara, P.C.
Headquarters: Washington, District of Columbia

13 The Best Lawyers in America® awards

3 Best Lawyers: Ones to Watch® in America awards

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Recognized in The Best Lawyers in America® 2025 for work in:
  • FDA Law

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