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Advancing Regulatory Science

Moving Regulatory Science into the 21st Century 

Graphic depicting FDA-regulated products Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.

FDA's  Advancing Regulatory Science Initiative builds on the achievements of existing Agency programs, like the Critical Path Initiative's groundbreaking efforts to transform the way medical products are developed, evaluated, and manufactured.


 

FDA Toxicology Roadmap cover

FDA Launches Predictive Toxicology Roadmap 

 


Strategic Plan for Regulatory Science

FDA has developed a strategic plan for regulatory science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.

Regulatory Science-Related Agency Activities

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