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FDA's Post-Shutdown ANDA Bolus Could Be Massive

 
• By Derrick Gingery

More than 300 generic drug applications might be officially filed when the shutdown ends, substantially increasing stress on assessors and other Office of Generic Drugs staff.

Generics

Another ANDA bolus is coming, although not because of a new US FDA policy or assessment time change.

If generic drug sponsors adhere to historical averages, the total number of applications processed upon the end of the government...

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