The FDA wants a new subcommittee of its Science Board to suggest ways to improve regulatory science at the Center for Devices & Radiological Health.
The FDA's Science Board yesterday agreed to form a new subcommittee to help the agency examine 3 specified domains of regulatory science activities related to medical devices, assess progress made since 2007, and address the challenges posed by rapidly evolving science and technology.
These challenges include the scientific implications of the increasing globalization of product development and supply chains, the federal watchdog agency noted in background materials released ahead of the meeting.
The FDA specifically requested that the new subcommittee make its recommendations with the agency's current staff and financial resources in mind, but also welcomed additional recommendations for steps the agency could take if new, additional resources for regulatory science are made available.
The new subcommittee will assess FDA's progress since 2007, when "FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology" was released. That report found that "the demands on the FDA have soared ... and the resources have not increased in proportion to the demands."
The previous subcommittee called for strategic leadership and support, including new resources; for strengthening science at FDA, with particular attention to emerging technologies; and for strengthening professional development, according to the agency.
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