Advances in FDA's Drug Safety Programs
Drug Safety is A Key Priority at the Center for Drug Evaluation and Research
Drug Safety Priorities 2018 (PDF- 12.85MB)
CDER Drug Safety Priorities 2018 is our third annual report detailing 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 2018, and describes several of the FDA’s most important efforts in drug safety science, surveillance, and oversight. The 2018 report joins the 2017 and 2015-2016 reports to offer a broad picture of FDA 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. 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—all activities that formed the foundation for the interdisciplinary scientific teamwork that is a hallmark of FDA’s drug safety oversight today.
Drug Safety Priorities 2017 (PDF - 4.5MB)