Tuesday, March 26, 2013

FDA Considers Compounding Industry User Fees

Hamburg: User Fees Might be Solution for Funding Increasing Regulation of Compounding Industry:

Hamburg said in her blog posting that FDA "looks forward to working with Congress to explore funding mechanisms, which could include registration or other fees, as Congress has authorized and FDA has successfully implemented in other settings."

Such funding might be able to bridge the gap between agency goals and resource limitations. Left unclear, however, is whether the pharmaceutical compounding industry would be on board with the proposal. Past user fee proposals, such as the Prescription Drug User Fee Act, the Medical Device User Fee Act and the Generic Drug User Fee Act have all been passed with the explicit support of their respective industries.

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