(At least on paper.)
As reported in BioCentury, FDA has 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.
Other priorities include addressing globalization; advancing safety and quality by reducing risks in the manufacturing, production and distribution processes; strengthening detection and surveillance of problems; and improving response to identified and emerging problems. The agency said it intends to increase the exchange of information with foreign sources by assembling global coalitions of regulators. Earlier this year, the agency launched an initiative to exchange information with EMA and the European Commission on foreign inspections, building on a three-year pilot launched in 2012. Comments are due July 31.
