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Zdrowie i gospodarka · 23.12.2014

Policy on Orphan-Drug Exclusivity; Clarification

The Food and Drug Administration (FDA) is publishing this document to clarify its policy regarding certain aspects of orphan-drug exclusivity. This document is being published because of a recent court decision interpreting provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Orphan Drug Act.

Source: Federal Register — Food and Drug AdministrationOpen original release →