Drug Safety is A Key Priority at the Center for Drug Evaluation and Research
Drug Safety Priorities 2019 (PDF-908KB)
CDER Drug Safety Priorities 2019 is our fifth 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 includes program updates and milestones achieved during 2019, and describes several of our most important efforts in drug safety science, surveillance, and oversight. The 2019 report joins the Center’s previous reports to offer a broad picture of our safety efforts, fueled by the synergies achieved through multidisciplinary collaborations and partnerships within CDER, across the FDA, and with stakeholders in industry, academia, the research community, and other federal agencies. 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.
Drug Safety Priorities 2018 (PDF- 12.85MB)
Drug Safety Priorities 2017 (PDF - 4.5MB)