FDA Releases Regulatory Science Plan

Posted: August 22, 2011

The US Food and Drug Administration (FDA) has released Strategic Plan for Regulatory Science, its  initiative to modernize the tools and methods that the agency uses to evaluate whether the products it regulates are safe for consumers.

According to the FDA, this regulatory science plan will be applied to both its pre-market review of efficacy and safety and its post-market product surveillance to review product quality. FDA 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 United States and global health and security; and
8. Strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products.

The above initiatives are further explained in Advancing Regulatory Science at FDA, a document outlining the plan.