Drug Safety is A Key Priority at the Center for Drug Evaluation and Research

CDER Drug Safety Priorities 2021 is our seventh annual report detailing the Center’s key safety programs and activities, and highlighting the depth and versatility of drug safety initiatives across CDER and the FDA.  The report highlights key safety-related milestones and accomplishments of 2021 and focuses on the programs and initiatives at the core of CDER’s drug safety operations.  It also features the many ways in which CDER has been involved in promoting and protecting public health during the SARS-CoV-2 coronavirus (COVID-19) pandemic.  Other safety-related reports issued earlier, all available below, describe actions CDER has taken in recent years to enhance the quality, accountability, and timeliness of its pre- and post-market drug safety decisions—activities that form the foundation for the interdisciplinary scientific teamwork that is a hallmark of FDA’s drug safety oversight today.