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

Executive Summary

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.

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ANDA Sponsors Given More Paperwork

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

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

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