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Research Field Public health, Drug discovery

Stimulating Regulatory Science

The FDA defines regulatory science as the “science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products.” FDA scientists have a unique vantage point from which to survey the drug development landscape. This collective regulatory knowledge can be leveraged to better understand the needs and opportunities for tools, standards and approaches in drug development. We believe advances in regulatory science are essential for the efficient development of new treatments and improved use of existing medicines.

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About the Authors

Jan Johannessen

Jan Johannessen is Deputy Director for Science, Scientific Collaborations, Office of Translational Science, Center for Drugs Evaluation and Research, FSA, USA.


Ameeta Parekh

Ameeta Parekh is Senior Advisor, Scientific Collaborations, Office of Translational Science, Center for Drugs Evaluation and Research, FSA, USA.

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