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May 8, 2024

GDUFA I

The Generic Drug User Fee Amendments of 2012 (GDUFA) was designed to speed access to safe and effective generic drugs to the public and reduce costs […]
May 7, 2024

FDA Roundup: May 7, 2024

For Immediate Release: May 07, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]
May 7, 2024

Drug Trials Snapshots: JOENJA

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
May 7, 2024

Drug Supply Chain Security Act (DSCSA)

Notify FDA of Illegitimate Products Manufacturers, repackagers, wholesale distributors, and dispensers are required to notify FDA within 24-hours after determining a product is illegitimate. Sign up […]
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