CDER's mission is to protect and promote public health by helping to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients. In support of this mission, the focus of regulatory science at CDER is on developing improved methods and approaches for evaluating new investigational drugs, manufacturing approved drugs, and monitoring drugs that are on the market.
About FDA’s Regulatory Science Program
To accomplish this mission, CDER scientists from multiple disciplines use a wide array of experimental and computer-based approaches. CDER scientists share their research in scientific journals, guidance for drug developers, and tools and resources for the drug development community.
Publications and Reports
- Regulatory Science Progress Report (FY 2015-2016) (PDF - 1.4 MB)
- Drug Safety-Related Regulatory Science Needs and Priorities
- Scientific Publications by FDA Staff
- What's New in Regulatory Science newsletter
CDER's Science and Research Programs Infographic
Within a science-based regulatory agency, such as CDER, 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.
Explore the CDER Science and Research Programs infographic to learn about the process that drives CDER science and research.