US FDA Hoping To Spur More ANDA Pre-Submission Meetings During GDUFA III

 
• By Derrick Gingery

The FDA believes conducting a pre-submission meeting when a complex generic application has unusual elements can increase the likelihood of a first-cycle approval.

Increase certainty
The FDA believes increasing pre-submission meetings for complex generic applications could boost first-cycle approvals. • Source: Alamy

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