Our regulatory science programs are intended to provide FDA reviewers, and the wider drug development community, with the knowledge and the tools they need to evaluate the safety and effectiveness of drug products.
Regulatory science aids the drug development community by supporting and streamlining development and testing of new products.
Microperfusion is a new technology that measures the concentration of drugs in the skin. It provides an efficient way to evaluate bioequivalence for prospective generics applied to the skin.
FDA meets with patients to get their perspective of the impact of their condition on their daily life and on their treatment. See how patients play a role in determining how drugs are developed.
FDA works with partners and consortia to help identify scientific gaps in drug development. Find out how these relationship improve FDA’s ability to review drugs.
Real-world evidence is information on patient’s health and health care that comes from multiple sources within and outside the clinical setting. Learn how FDA is using it.
Data standards make the exchange of data predictable and consistent and ensure data is in a form that scientific tools can use. Learn how data standards are improving drug review at CDER.