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FDA Hiring Campaign Continues; Goal Is Addressing Pending ANDAs

Executive Summary

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

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ANDA Submissions Continue Yo-Yo Pattern, Unlike Approvals

After spike in March, generic drug application submissions drop 62% in April, while approval volume remains at monthly average.

ANDA Submissions Continue Yo-Yo Pattern, Unlike Approvals

After spike in March, generic drug application submissions drop 62% in April, while approval volume remains at monthly average.

A Burning FDA Hiring Freeze Question: What About User Fee-Supported Staff?

Industry worries about user fee programs as US FDA could wait weeks before finding out how President Trump's hiring freeze affects it.

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