Business · 30/03/2000Updated: 10/17/2026 · 1 min read
FDA Releases Guidance on Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under Hatch-Waxman Act
Summary
The FDA has published a guidance document to clarify its application of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, following recent court decisions on abbreviated new drug applications and generic drug exclusivity
Original source language: Federal Register — Food and Drug AdministrationOpen original release →