The FDA Office of the Chief Scientist invited Almut Winterstein, R.Ph., Ph.D., FISPE, to deliver a presentation on the comparative effectiveness of risk mitigation strategies for prescription drugs on Dec. 12 in Washington, D.C. The presentation was broadcast across the FDA and focused on evidence gaps and the public health impact of risk mitigation strategies that are implemented by the FDA for drugs that require specific precautions to ensure they are safe. Her research has demonstrated several shortcomings of currently implemented risk mitigations strategies that are aimed at preventing fetal exposure to drugs that can cause birth defects. Winterstein is a professor and the Robert and Barbara Crisafi Chair in Pharmaceutical Outcomes and Policy in the UF College of Pharmacy and director of the UF Center for Drug Evaluation and Safety. She previously served as chair of the FDA Drug Safety and Risk Management Advisory Committee from 2012-18.