Tag: Hatch-Waxman Act
Jan, 17 2026
An ANDA, or Abbreviated New Drug Application, is the FDA pathway that allows generic drugs to enter the market without repeating costly clinical trials. It saves billions annually and makes essential medicines affordable.
Generic drugs now make up over 90% of U.S. prescriptions, saving billions annually. This is their story - from dangerous 19th-century medicines to the Hatch-Waxman Act and modern supply chain challenges.
The FDA Office of Generic Drugs ensures affordable, high-quality generic medications reach patients by reviewing applications, enforcing bioequivalence standards, and managing patent exclusivity under GDUFA and the Hatch-Waxman Act.
