Ms. Gail Javitt Johns Hopkins University, USA

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Gail 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... read moreCLIA 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. 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.