FDA Drafts New Five-Year Priority Document

FDA Drafts New Five-Year Priority Document-thegraysheet: FDA’s proposed a new five-year strategic priorities plan has many similarities to last time the agency set such an agenda to paper in 2011, but it introduces some new concepts for its cross-cutting priorities and reorganizes its goal-setting approach, with more explicit attention to device postmarket surveillance, for instance. The 2014-2018 draft plan, issued June 30, retains the basic concepts of regulatory science, globalization and safety/quality enforcement as cross-cutting priorities. It highlights two new top-line agenda items: so-called smart regulation, which means balancing protecting the public with encouraging innovation, and stewardship, which reflects the increasingly challenged fiscal environment that FDA is contending with.