Tag: bioequivalence
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.
MoreCombination NTI Drugs and Generic Availability: Coverage and Gaps
Posted by Michael Sumner in Pharmaceuticals
3Jan
Combination NTI drugs offer powerful treatment for complex conditions, but generic versions are nearly nonexistent due to unmet bioequivalence standards. Patients face higher risks, costs, and monitoring burdens with few safe alternatives.
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