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Tag: bioequivalence

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.

Special Populations in Bioequivalence: Age and Sex Considerations

Special Populations in Bioequivalence: Age and Sex Considerations

Bioequivalence studies must reflect real patients. Learn how age and sex differences impact generic drug safety and why regulators now require balanced enrollment in clinical trials.

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