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FDA Unveils Strategic Plan for Regulatory Science

The plan focuses on eight priority issues.

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By: TOM BRANNA

Editor

The US Food and Drug Administration 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. The plan identifies eight priority areas of regulatory science 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
  8. Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products
FDA will apply available resources to implement the Strategic Plan for Regulatory Science through management of scientific programs within FDA and engagement of collaborators and partners in industry, academia and government.FDA’s Strategic Plan for Regulatory Science is designed to allow the Agency both to meet today’s public and animal health needs and to be fully prepared for the challenges and opportunities of tomorrow to help harness revolutions in science that can be translated into products that help make and keep our nation both safe and healthy.

More info: www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm268095.htm

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