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Complex Generics: US FDA, Sponsors View Roadblocks Very Differently

 
• By Derrick Gingery

As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.

FDA building
The US FDA approval process for complex generic drugs continues to vex sponsors, who want a more predictable timeline • Source: Shutterstock

ANDA sponsors feel some more tweaking of the assessment process is necessary to speed approval of complex generics, but the US Food and Drug Administration appears more willing to wait for the current process to bear fruit.

In what may be a rare case of indirectly open generic drug user fee reauthorization negotiating, generic sponsors suggested several...

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