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

The FDA conducts regulatory science research, which is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of certain FDA-regulated products. This research facilitates evaluation or development of FDA-regulated products and supports regulatory decision-making and policy development. It also enables the FDA to understand and assess risk, prepare for and respond to public health emergencies, and help ensure the safety or reduce the harm of products used or consumed by patients and consumers.

The 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted 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.

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• FDA In Brief: FDA Publishes Report on Focus Areas of Regulatory Science

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