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Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes

 
• By Derrick Gingery

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

Clock near deadline
FDA agreed to issue the ANDA labeling assessment closer to the goal date in order to avoid delays from late changes by reference product sponsors. • Source: Alamy

A subtle change in the GDUFA III commitment letter would change the timing of labeling assessments and potentially limit or eliminate delays from last-minute reference product labeling changes.

During the first assessment cycle, the US Food and Drug Administration will strive to wait to issue any discipline review...

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