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Gail H. Javitt
Member of the Firm at Epstein Becker Green, USA

Profile

GAIL H. JAVITT is a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC,
office of Epstein Becker Green. Ms. Javitt provides strategic FDA regulatory advice for leading medical device,
diagnostics, pharmaceutical, biological products, human cellular, and tissue-based products (HCT/Ps), and dietary
supplement companies 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 services include:


 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


Ms. Javitt’s experience prior to joining Epstein Becker Green includes serving as counsel in a major Washington, DC,
FDA Regulatory 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 and science, 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.

Gail H. Javitt's Network