FDA pledges review process makeover

Tools

The FDA's 2011 budget request, as reported earlier, includes $25 million for a 50-person regulatory science initiative to help the watchdog catch up with industry capabilities in the life sciences. Nanotechnology is a prime target for expertise development, according to the budget request, as is stem cell technology. Additional targets include the update of review standards and the formation of regulatory pathways for new technologies and for biosimilars (see related story).

The FDA identifies the initiative as the first major effort to address "scientific gaps" identified in 2007's FDA Science and Mission at Risk, which concluded that the agency is unable to fulfill its mission partly because it lacks the scientific expertise.

The fix, says the regulator, starts with the FDA's chief scientist forming an office of science and innovation. This new entity will drive leadership and coordinate external collaborations "for the development of core capacities and modern product evaluation standards." Jesse Goodman is currently acting chief scientist, as well as deputy commissioner for science and public health.

PhRMA favors the initiative, saying it "supports the FDA's commitment to elevate the discipline of regulatory science ... based upon the best and most up-to-date scientific thinking."

- here's the budget request

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