Tag: Hatch-Waxman Act

FDA Authorization of Generics: Legal Basis and Approval Process Explained

Posted On July 24, 2026 0

Explore the FDA's legal basis for authorizing generic drugs via the Hatch-Waxman Act and ANDA process. Learn how bioequivalence ensures safety while lowering costs for 90% of US prescriptions.

First Generic Approval: Why It Matters for Drug Prices and Patient Access

Posted On May 17, 2026 0

Discover why first generic approval matters for drug prices and patient access. Learn about FDA exclusivity, the Hatch-Waxman Act, and how Paragraph IV certifications drive competition in the pharmaceutical industry.