FDA outlines regulatory science strategic plan
The FDA recently released its strategic plan for advancing regulatory science, including its intent to enhance the process for developing and evaluating new products and materials from fields such as cell therapy, tissue engineering, genomics, personalized medicine, advanced computing and IT. The August publication, titled “Advancing Regulatory Science at FDA,” outlines its priorities.
The plan also emphasizes the agency’s intention to study and improve how it communicates health information to consumers, particularly as communication technologies evolve and change the way people receive that information.
“The core responsibility of the FDA is to protect consumers by applying the best possible science to its regulatory activities – from pre-market review of efficacy and safety to post-market product surveillance to review of product quality,” the report stated. In the past few years, rapid advances in science have meant new technologies to discover, manufacture and assess and to improve food safety and quality.
“The FDA must keep pace with and utilize these new scientific advances in order to accomplish its mission to protect and promote the health,” the report said.
The priorities include:
The plan also emphasizes the agency’s intention to study and improve how it communicates health information to consumers, particularly as communication technologies evolve and change the way people receive that information.
“The core responsibility of the FDA is to protect consumers by applying the best possible science to its regulatory activities – from pre-market review of efficacy and safety to post-market product surveillance to review of product quality,” the report stated. In the past few years, rapid advances in science have meant new technologies to discover, manufacture and assess and to improve food safety and quality.
“The FDA must keep pace with and utilize these new scientific advances in order to accomplish its mission to protect and promote the health,” the report said.
The priorities include:
- Modernize toxicology to enhance product safety;
- Stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes;
- Support new approaches to improve product manufacturing and quality;
- Ensure FDA readiness in evaluating innovative emerging technologies;
- Harness diverse data through information sciences to improve health outcomes;
- Implement a new prevention-focused food safety system to protect public health;
- Facilitate medical countermeasure development to protect against threats to the U.S. and global health and security; and
- Strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products.