While the money won’t be there as originally expected, the Food and Drug Administration (FDA) is continuing with its efforts to expand and strengthen its work in regulatory science. Yesterday the FDA released its report/strategic plan Advancing Regulatory Science at FDA (H/T ScienceInsider). It’s not terribly different from the general ideas outlined in a different report last fall.
The report identifies and explains eight areas of emphasis moving forward. They are a mix of categories of regulation to focus on and areas meant to improve the processes associated with FDA testing and regulation.
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 Science 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
While there are no deadlines included in this plan, there are specific steps and tools described for implementation. As the research money associated with this program was already small, any cuts will make it difficult to meet near-term deadlines.