Premarket Safety Review and Marketed Drug Safety are Equal Priorities at the Center for Drug Evaluation and Research
CDER Drug Safety Priorities 2015-2016 details both the Center’s key safety priorities as well as the depth and versatility of drug safety initiatives across CDER and the FDA. The report includes program updates and milestones achieved since the start of 2015, describing several of the FDA’s most important efforts in drug safety science, surveillance, and oversight. The report seeks to offer a broad picture of current safety efforts, and highlights the critical advantages gained in safety science through a range of multidisciplinary collaborations and partnerships—within CDER and across the FDA, and with stakeholders from other government agencies, patient communities, industry, and academia.
Safety reports issued earlier describe actions CDER has taken in recent years to enhance the quality, accountability, and timeliness of its postmarket 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.