1. Pink Sheet

GDUFA III: Convening Enhanced Mid-Cycle Meeting Will Cost Sponsors

 
• By Derrick Gingery

Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.

Extend deadline pull-down menu
The GDUFA III commitment letter includes several new meeting opportunities, as well as new suitability petition response goals. • Source: Alamy

A new type of meeting offering more detailed mid-assessment advice from the US Food and Drug Administration about generic drug applications will cost applications more valuable time.

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