About Gail
Gail H. Javitt: Strategic FDA Regulatory Counsel
Gail H. Javitt is a leading expert in FDA regulatory law, providing strategic guidance and robust legal counsel to a diverse range of clients in the medical device, pharmaceutical, biological product, and human cellular/tissue-based product sectors. With a proven track record of success spanning the product lifecycle – from initial development through post-market surveillance – Ms. Javitt offers unparalleled expertise in navigating the complexities of the U.S. Food and Drug Administration (FDA) regulatory landscape. She is particularly adept at resolving disputes at both the pre- and post-market stages, consistently advocating for her clients’ interests and safeguarding their market access.
Ms. Javitt’s career is distinguished by a deep understanding of scientific and policy issues, combined with a sharp legal mind. Prior to joining her current practice, she served as a partner in a prominent Washington, D.C. health law practice, demonstrating extensive experience in advising on a wide spectrum of legal and regulatory matters. Furthermore, she played a pivotal role as a Law and Policy Director at the Genetics and Public Policy Center, part of Johns Hopkins University, where she spearheaded the development of policy options concerning the burgeoning field of reproductive and other genetic technologies, showcasing her commitment to innovation and responsible regulation.
Early in her legal career, Ms. Javitt gained invaluable experience as a law clerk for the Honorable Gary Taylor of the U.S. District Court for the Central District of California, honing her analytical and research skills within a demanding judicial environment. This foundational experience, coupled with her academic achievements, establishes her as a highly capable and respected legal professional.
Ms. Javitt is a prolific speaker and author, consistently contributing to the ongoing discourse at the intersection of law, science, ethics, and policy. Her expertise encompasses critical areas such as FDA regulation of genetic testing, precision medicine, and next-generation sequencing. She has been a valued faculty member at prestigious institutions including the Berman Institute of Bioethics at Johns Hopkins University and as an adjunct professor at Georgetown University Law Center, American University’s Washington College of Law, and the University of Maryland School of Law. As a Greenwall Fellow in Bioethics and Health Policy – a collaborative effort between Johns Hopkins University and Georgetown University – Ms. Javitt’s work further underscores her dedication to ethical and responsible innovation within the healthcare industry.
Key Practice Areas:
- FDA Regulatory Law: Ms. Javitt provides comprehensive strategic advice and representation to clients seeking to obtain FDA approvals for their products, including medical devices, diagnostics, pharmaceuticals, biological products, and human cellular and tissue-based products (HCT/Ps).
- Pre- and Post-Market Regulatory Support: She offers extensive support throughout the product lifecycle, including submissions, interactions with the FDA, risk management, and addressing adverse event reporting.
- Clinical Laboratory Regulatory Guidance: Ms. Javitt provides expert counsel to clinical laboratories on FDA and Clinical Laboratory Improvement Amendments (CLIA) requirements for laboratory-developed tests (LDTs), ensuring compliance and successful market authorization.
- Dispute Resolution: Successfully resolves disputes at both the pre- and post-market stages, leveraging her deep regulatory knowledge to achieve favorable outcomes for her clients.
Education & Credentials:
- Awards: Recognized in Best Attorney USA since 2025
- Professional Affiliations: (Information Pending – Focus remains on expertise)
- Education: Clerkship for the Honorable Gary Taylor, U.S. District Court for the Central District of California
- Academic Experience: Faculty Member, Berman Institute of Bioethics at Johns Hopkins University; Adjunct Professor, Georgetown University Law Center, American University’s Washington College of Law, and the University of Maryland School of Law; Greenwall Fellow in Bioethics and Health Policy (Johns Hopkins University & Georgetown University)
Ms. Javitt’s dedication to her clients and her profound understanding of the FDA regulatory process make her a trusted and invaluable partner for companies seeking to bring innovative products to market while navigating the complexities of federal regulations. Her proactive approach, combined with her commitment to achieving successful outcomes, sets her apart as a leading counsel in this critical field. She is committed to providing proactive legal counsel that protects her clients' investments and future success.
