Tag: OGD

FDA Office of Generic Drugs: Role, Responsibilities, and Structure Explained

FDA Office of Generic Drugs: Role, Responsibilities, and Structure Explained

Feb, 28 2026

The FDA Office of Generic Drugs (OGD) ensures safe, affordable generic medications reach patients by reviewing applications, enforcing bioequivalence standards, and managing patent rules under GDUFA and Hatch-Waxman. It's the backbone of the U.S. generic drug system.

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