Back to Science and Research (Drugs)
Within a science-based regulatory agency, such as the Center for Drug Evaluation and Research (CDER) at the FDA, the focus of science and research programs is to obtain knowledge that enhances the efficiency and consistency of the regulatory decision-making process. CDER scientists also strive to remain at the cutting-edge in order to respond quickly to unforeseen public health emergencies when new tools and techniques are required. Science and research programs support CDER's mission to ensure the availability of drug products with proven efficacy, safety and consistent quality, and to monitor product safety during real-world use.
Visit the infographic to view the underlying process – from identification of a new question to synthesis of knowledge and update of regulatory recommendations – that drives the wide variety of CDER science and research programs. Text from this infographic is also shown below.
Knowledge Gaps and Questions that underlay medical product development – such as questions from drug application reviewers, post-market observations, or new and emerging technologies – are usually very specialized. CDER scientists address current questions and strive to predict potential, future knowledge gaps in order to be proactive in their support of the FDA’s mission to protect public health.
Science and Research Programs - CDER scientists possess the expertise and tools necessary to execute applied research to address these specialized questions. CDER also reaches out to stakeholders who have regulatory science and research projects in progress. These public private partnerships with sponsors, academia and other government research organizations prevent duplication of effort and allow research resources to be used more effectively.
Report Scientific Findings - Research results and scientific findings are reported to the scientific community in peer reviewed journals and at scientific conferences.
Update Regulatory Guidances, Standards, Methods and Capabilities - CDER regulatory science and research findings provide the basis for recommendations to sponsors in the form of regulatory guidances, standards, or best practices methods. These recommendations give sponsors clear processes on how to shape, conduct, & analyze clinical and non-clinical studies and provide guidance to ensure the integrity, quality, & safety of medical products during their entire life cycle.
Scientific and Regulatory Knowledge - Knowledge and recommendations obtained from CDER’s science and research projects provide a more reliable, predictable, transparent, consistent, and efficient review process. Scientific knowledge gained through these activities also allows CDER to respond swiftly to unforeseen public health emergencies. Greater certainty in existing and emerging medical product technologies gives confidence to regulatory stakeholders who will continue to improve medical technologies leading to new questions and new knowledge to continue the research cycle.