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February 4th, 2010

FDA pledges review process makeover

Abstract:
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.

Source:
fiercepharmamanufacturing.com

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