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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

US Food and Drug Administration officials hope changes to the ANDA pre-submission meeting will create more value and generate more complex generic sponsor interest, which could lead to faster approvals.

Pre-submission meetings allow an ANDA sponsor to discuss the structure of an upcoming submission with FDA assessors and highlight areas with unique or novel data

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