Gail H. Javitt Director 202-737-4580

Overview

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

Education & Admissions

Education

M.P.H., Johns Hopkins Bloomberg School of Public Health
J.D., cum laude, Harvard Law School
B.A., magna cum laude, Columbia College, Columbia University

Experience

  • Filing a Citizen Petition seeking a change in FDA’s approach to the regulation of pharmacogenetic testing
  • Providing premarket strategic advice to clients interested in bringing innovative medical technologies to market
  • Advising on the NDA, 510(k), and PMA review pathways and the regulatory implications of post-market product modifications
  • Counseling clients on clinical trial (GCP) compliance, including the responsibilities of sponsors and investigators, IRB engagement, and the submission of investigational device exemption (IDE) and investigational new drug (IND) submissions
  • Preparing client communications to FDA, including requests for designation, Citizen Petitions, and comments to proposed regulations and guidance documents, and representing clients in engagements with the agency
  • Providing post-market compliance counseling, including medical device reporting and corrections and removals, and assisting clients in resolving Form 483 inspectional observations and Warning and Untitled Letters

Speaking Engagements

  • Legal & Policy Problems in Genomic Research & Clinical Care, LawSeq: Facing the Legal Barriers to Genomic Research & Precision Medicine, March 27,2020
  • National Academies, Genomics Roundtable, March 25, 2020
  • Exploring the Current Landscape of Consumer Genomics – A Workshop, National Academies of Sciences, October 29, 2019.
  • Innovator Meets Regulator, AI Applications for Drug Discovery and Development, Sept. 12, 2019
  • Investigational Device Exemptions, FDLI/CDRH In-House Training Course (Introduction to Medical Device Law and Regulation), June 14, 2019
  • FDA & Artificial Intelligence, Harvard Medical School Biomed Salon, Dec. 12, 2018
  • The Regulatory Landscape for Clinical NGS: Where Are We and Where Should We Be Going , Aug. 20, 2018
  • Investigational Device Exemptions, FDLI/CDRH Introduction to Medical Device Law and Regulation In-House Training Course, 2018
  • A Conversation About FDA Regulatory Guidelines for Genomics, Understanding Your Genome Conference, Nov. 14, 2017
  • Clinical Investigations: Sponsor Responsibilities and Compliance Issues, Food and Drug Law Institute, Nov. 2, 2016
  • Introduction to Device Law & Regulation Workshop: Enforcement & Compliance, Food and Drug Law Institute, Jun. 14, 2016
  • Wellness and Wearables, Food and Drug Law Institute, Mar. 31, 2016
  • Genetic Testing: Marketing and Regulatory Issues. Guest Lecture, U. Michigan School of Pub. Health, Nov. 4, 2016, Dec. 1, 2015
Education

M.P.H., Johns Hopkins Bloomberg School of Public Health
J.D., cum laude, Harvard Law School
B.A., magna cum laude, Columbia College, Columbia University

Practice Areas
Industries
FDA Regulatory Categories