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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.

2022 Focus Areas of Regulatory Science (FARS) Cover

2022: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science

This report—updated for 2022—outlines the Focus Areas of Regulatory Science (FARS) that FDA has identified 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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