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A Look Back at Risk Evaluation and Mitigation Strategies at the Food and Drug Administration in 2020: Year in Review

December 14, 2020

In the latest issue of the Food and Drug Law Institute (FDLI) Update Magazine, David Shotlander and Tiffany Jang provide an overview of major FDA Risk Evaluation and Mitigation Strategies (REMS) news from the past year, including

  • Enactment of the CREATES Act, which remained unasserted in its first year;
  • FDA’s discretionary suspension of certain REMS requirements during the COVID-19 public health emergency; and
  • A recent U.S. Department of Health and Human Services Office of Inspector General report that examined FDA oversight of opioid REMS programs.

To read the full article A Look Back at Risk Evaluation and Mitigation Strategies at the Food and Drug Administration in 2020: Year in Review with permission of FDLI, please visit here.