Wednesday, February 01, 2012 12:28 PM
FDA Doubles User Fees; Promises Faster Reviews
Device makers agree to double the fees they pay to FDA, to $595 million, in turn for faster, more predictable review process.
The U.S. Food and Drug Administration has agreed to speed up reviews of new medical implants in return for doubling the user fees from manufacturers, under a preliminary agreement. This agreement is expected to fetch FDA $595 million in user fees to the FDA over five years, allowing the agency to hire 200 new scientists. This amount is twice that of the $295 million industry paid over the last five years of the arrangement. While not final, the agreement assures the continuat more...
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