This year marks the 10-year anniversary of the Food and Drug Administration Amendments Act (FDAAA), which granted FDA the authority to require risk evaluation and mitigation strategies (REMS). REMS is becoming increasingly significant to both the innovator and generic industries. This webinar will discuss key aspects of FDA practice and guidance, enforcement trends, and considerations for the development of single, shared system (SSS) REMS. Speakers will also address how the CREATES Act legislation, which would create a cause of action to obtain restricted product samples and facilitate shared REMS, has the potential to impact the future of SSS REMS development. The CREATES legislation was introduced in 2016, and may be included as part of the User Fee Act (UFA) legislative package.
Katlin Backfield, Attorney and Consultant, Backfield PLLC
Abby Brandel, Attorney, Office of the Chief Counsel, FDA
Lynn Mehler, Partner, Hogan Lovells LLP
Moderated by Carla Cartwright, Director, Federal Affairs, Johnson & Johnson