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Drug Review Regulation BioPharmaceutical

ANDA Approvals, Submissions Decline With New Review Goal Coming

  • Analysis

Executive Summary

Is a rush of generic applications seeking the 10-month clock on the way?

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ANDA Approvals, Complete Responses Hit Record In FY 2016

FDA's Office of Generic Drugs completes its best year of the GDUFA era.

FDA Hiring Campaign Continues; Goal Is Addressing Pending ANDAs

GDUFA funding will bring 50 additional people to the Office of Pharmaceutical Quality for generic drug review purposes.

GDUFA II: ANDAs, Not Facilities Will Govern Revenue

Since applications comprise most of the workload, they will be the focus in the next generic drug user fee cycle.

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