Drug Shortage Scrutiny: GAO Plans Study Of FDA’s Expedited Applications

 
• By Derrick Gingery

Government watchdog wants to look at how the agency expedites applications that could help alleviate a shortage, but cautions that process alone cannot reduce shortages.

FDA’s practice of expediting approvals of generic drug applications that could help alleviate a shortage will come under additional scrutiny.

The agency indicated it is using its regulatory flexibility to push some applications through their reviews faster, but the Government...

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