Tag: Hatch-Waxman Act
FDA Authorization of Generics: Legal Basis and Approval Process
Posted by Michael Sumner in Pharmaceuticals
26Jan
The FDA approves generic drugs through the ANDA pathway created by the Hatch-Waxman Act, ensuring they are bioequivalent, safe, and affordable. Over 90% of U.S. prescriptions are filled with generics, saving billions annually.
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