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Tag: Hatch-Waxman Act

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

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

Explore the FDA Office of Generic Drugs (OGD): its structure, role in approving generic meds, and impact on drug safety and affordability under GDUFA.

Patent Term Restoration Guide: How to Extend Pharmaceutical Exclusivity

Patent Term Restoration Guide: How to Extend Pharmaceutical Exclusivity

Learn how patent term restoration extends pharmaceutical exclusivity to recover time lost during FDA reviews under the Hatch-Waxman Act.

FDA Orange Book: Where to Find Patent Expiration Dates for Generic Drugs

FDA Orange Book: Where to Find Patent Expiration Dates for Generic Drugs

Learn how to find patent expiration dates in the FDA Orange Book to determine when generic drugs can enter the market. Understand patent extensions, exclusivity, and common pitfalls.

FDA Authorization of Generics: Legal Basis and Approval Process

FDA Authorization of Generics: Legal Basis and Approval Process

The FDA approves generic drugs through the Hatch-Waxman Act's ANDA pathway, requiring identical active ingredients, bioequivalence, and strict manufacturing standards. Generics cost 80-85% less and make up 90% of U.S. prescriptions.

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