Tag: GDUFA

FDA Office of Generic Drugs: Role, Responsibilities, and Structure Explained
FDA Office of Generic Drugs: Role, Responsibilities, and Structure Explained
Jan, 14 2026 Medications Bob Bond
The FDA Office of Generic Drugs ensures safe, affordable generic medications reach patients by reviewing applications, enforcing quality standards, and managing patent rules under GDUFA and Hatch-Waxman. Learn how it works and why it matters.