FDA Issues Strategic Plan for Regulatory Science
This post was written by Erin Janssen.
On August 17, 2011, the FDA released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security. The plan addresses regulatory science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. Eight priority areas of regulatory science are identified where new or enhanced engagement is essential to the continued success of FDA’s public health and regulatory mission. The priority areas are: (1) Modernize Toxicology to Enhance Product Safety; (2) Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes; (3) Support New Approaches to Improve Product Manufacturing and Quality; (4) Ensure FDA Readiness to Evaluate Innovative Emerging Technologies; (5) Harness Diverse Data through Information Sciences to Improve Health Outcomes; (6) Implement a New Prevention-Focused Food Safety System to Protect Public Health; (7) Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security; and (8) Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products.
