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GDUFA III: US FDA Says Generic Drug Supplement Volume Could Require More Resources

 
• By Derrick Gingery

Will the growing workload cause GDUFA fees to increase or prompt other changes?

closeup of a young caucasian doctor showing a signboard with the text generic drugs written in it
Controlled correspondence submissions also continue to increase and many relate to complex products. • Source: Shutterstock

Supplement volume is becoming a problem for the US Food and Drug Administration’s generic drugs program, which could signal user that fee program adjustments are under consideration.

Submissions of prior approval supplements (PASs) and changes being effected (CBE) supplements have been rising steadily for several years, FDA officials told industry representatives during a 17 December generic drug user fee reauthorization negotiation session

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