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Generic Drugs Review Pathway Regulation

Unhappy With GDUFA II? Note It For GDUFA III, FDA Says

  • Analysis

Executive Summary

US agency says it is implementing generic drug user fee program as outlined in commitment letter and any changes should be discussed at negotiations for the 2022 renewal.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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