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  1. Regulatory Science in Action

Dr. Woodcock on Regulatory Science

Educational videos on select regulatory science topics by the Director of CDER

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.


About FDA's Regulatory Science Program

Transcript

Regulatory science aids the drug development community by supporting and streamlining development and testing of new products.


How Regulatory Science Benefits Patients

Transcript

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.


Patient-Focused Drug Development

Podcast    Transcript

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.


The Importance of Partnerships and Consortia

Podcast    Transcript

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

Podcast    Transcript

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.


Improving Drug Review with Data Standards

Podcast    Transcript

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.