FDA Strategic Plan Outlines Steps for Advancing Regulatory Science

September 1, 2011 8:59 AM

FDA has released “Advancing Regulatory Science at FDA: A Strategic Plan,” a publication outlining the agency’s strategic plan for facilitating the development and evaluation of new treatments and innovative medical products, so that the products can be brought to market more efficiently. FDA Commissioner Margaret A. Hamburg, MD, stated in a press release that, “As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy. It positions us to foster innovation through better science without compromising our high safety standard.” The strategic plan details the objectives and benefits of eight FDA science priority areas:

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 US and Global Health and Security
8. Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products

More information about the FDA Advancing Regulatory Science initiative, introduced in October 2011, is available on page 208 of the November-December 2010 NABP Newsletter (PDF).