21st Century Cures Act

The 21^st Century Cures Act—signed into law by the President on Tuesday, December 13, is sweeping bipartisan legislation intended to advance the research and development of new therapies and diagnostics and that makes substantial federal investments in a wide range of health care priorities. The Act’s changes to the Federal Food, Drug, and Cosmetic Act are significant, clarifying and creating new FDA authorities over drugs, including regenerative advanced therapies; medical devices, including certain health software; and combination products; as well as FDA’s administrative authorities. Join FDLI for an overview of the FDA-related sections of this new law while hearing directly from those intimately involved in the legislation.

 

Eva Temkin, Counselor, Office of the Chief Counsel, FDA
Wade Ackerman, Partner, Covington & Burling LLP
Marcy Busch, Counselor, Office of Chief Counsel, FDA 
Moderated by Carla Cartwright, Director, Global Regulatory Policy & Intelligence, Janssen Pharmaceuticals Inc.