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Advancing Regulatory Science

Moving Regulatory Science into the 21st Century 

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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.


2021 Focus Areas of Regulatory Science (FARS) Cover

2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science

This report outlines the Focus Areas of Regulatory Science (FARS) identified by FDA as needing continued investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making and improve guidance to sponsors. Each FARS aligns with one of four strategic initiatives.

View the report


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FDA Launches Predictive Toxicology Roadmap 


Regulatory Science-Related Agency Activities

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