FDA Issues Regulatory Science Modernization Plan

(FDA.gov)

The U.S. Food and Drug Administration today released its Strategic Plan for Regulatory Science that calls for modernization of the science used to protect the nation’s food and drug supplies. The plan describes the agency’s intent to improve the ways it develops and evaluates new products and materials, as well as improve the way it communicates health information to consumers.

FDA calls regulatory science the foundation of its decision-making, and the plan outlines how the agency expects to modernize the tools and methods used to evaluate the safety and effectiveness of the products under its mandate. The plan lists eight priorities for modernization:

– Modernize toxicology to enhance product safety, including improvement of tests, models and measurements to predict product safety issues. This includes, where feasible, the development of new methods that could reduce or replace animal testing.

– Stimulate innovation in clinical evaluations and personalized medicine, such as new tools and processes for getting the right medicine to the right person at the right time.

– Support new and improved manufacturing methods by researching how new technologies can enhance product safety and effectiveness.

– Ensure FDA readiness to evaluate innovative emerging technologies with the necessary expertise and infrastructure.

– Harness a wider array of data through information sciences to improve health outcomes, including an upgrade of FDA’s information technology to support sophisticated data analyses.

– Implement a new prevention-focused food safety system mandated by the Food Safety Modernization Act passed by Congress and signed into law in January 2011.

– Encourage development of medical countermeasures to protect against threats to U.S. and global health and security, including drugs, vaccines, diagnostic tests, and personal protective equipment.

– Develop a communications strategy based on social and behavioral science that will help FDA adapt to technologies that are changing the way people receive and share information.

The plan notes that FDA may be a science agency, but not a large external funding agency, and as a result needs to take steps to keep refreshing its ideas through collaborations, staff training, and professional development. The collaborations include those with other federal agencies (e.g., NIH), not-for-profit organizations, public-private partnerships.

Read more: FDA Outlines Regulatory Science Needs for Drug Evaluations

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