Guidance for Industry on Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act." The purpose of this guidance is to inform the public of FDA's application of the abbreviated new drug application (ANDA) approval provisions and 180-day generic drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act (the act) in light of recent court decisions on these issues.