Business · 19/11/2014Updated: 10/17/2026 · 1 min read

FDA Opens Public Docket for Proposed Criteria on 'First Generic' ANDA Submissions

Summary

The FDA is seeking public comments on proposed criteria for prioritizing 'first generic' abbreviated new drug application (ANDA) submissions, aiming to improve review prioritization under the Generic Drug User Fee Amendments of 2012 (GDUFA)

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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