Generic Drug User Fee Amendments (Jul 30, 2025 12:43)
This page features news and information for industry and stakeholders about GDUFA, its ...

GDUFA User Fee Rates Archive (Jul 30, 2025 12:41)
GDUFA User Fee Rates Archive

Hiding in Plain Sight: 7-OH Products (Jul 30, 2025 10:14)
7-OH: Emergence of a Fourth Opioid Epidemic

Generic Drug Facilities, Sites and Organization Lists (Jul 30, 2025 10:03)
Generic Drug Facilities, Sites and Organization Lists

Competitive Generic Therapy Approvals (Jul 30, 2025 09:47)
Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into th...

Prescription Drug User Fee Amendments (Jul 30, 2025 08:45)
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authoriz...

Drugs@FDA Data Files (Jul 30, 2025 08:44)
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationsh...

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