Tag: Hatch-Waxman Act
What is an ANDA? Abbreviated New Drug Application Explained for Generic Medicines
Maddie Shepherd
Dec
5
2
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An ANDA is the FDA pathway that lets generic drug makers prove their products work just like brand-name drugs - without redoing costly clinical trials. It’s how 90% of U.S. prescriptions are filled at a fraction of the cost.
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Patent Litigation and Generic Entry: How Paragraph IV Drives Affordable Medicines
Maddie Shepherd
Nov
16
12
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Paragraph IV under the Hatch-Waxman Act lets generic drug makers challenge brand patents to bring cheaper medicines to market faster. Learn how it works, why it matters, and how it saves billions for patients.
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