Will US FDA Offer Regulatory Flexibility For ANDAs Downgraded Because Of CRO Investigation?

 
• By Derrick Gingery

Complex generic may have some wiggle room, but the only choice for many sponsors may be to redo the affected studies or withdraw the products that have lost bioequivalence status after FDA questioned the integrity of the data from two contract researchers.

Two doors, two choices
The FDA is offering most sponsors two doors, redoing the BE studies or withdrawing the application, but each has its own challenges. • Source: Alamy

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