BioCentury
ARTICLE | Politics & Policy

Regulatory science and globalization top FDA's four-year plan

July 2, 2014 12:21 AM UTC

FDA released a draft four-year plan for 2014-2018 that reiterates its emphasis on advancing regulatory science. The agency said it plans to increase the use and capacity of regulatory science -- which it defines as the science of developing tools, standards and approaches to assess the safety, efficacy, quality, toxicity, public health impact or performance of a food or medical product -- to inform standards development, analysis and decision-making and to effectively evaluate products.

In the agency's strategic priorities for 2011-2015, the advancement of regulatory science was listed as the top priority for the agency as a whole. FDA has since published a strategic plan for regulatory science, which details eight priority areas and calls on the agency to collaborate with stakeholders to develop and refine clinical trial designs (see BioCentury Extra, Aug. 17, 2011). ...