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Generic User Fee Transition A Little Bumpy For Contract Manufacturers

 
• By Derrick Gingery

Problems with self-identification process caused by timing of legislative renewal may have affected figures used by US FDA to calculate FY 2018 GDUFA fees.

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Contract manufacturers apparently did not join the US FDA generic drug user fee program's facility self-identification process as smoothly as intended, due in part to unfortunate timing of the legislative renewal of the program that prevented guidance development.

FDA asks generic drug manufacturers to voluntarily report their facilities and associated functions each year to help the agency keep...

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