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Zdrowie i gospodarka · 14/07/1998

FDA Releases Guidance on 180-Day Generic Drug Exclusivity Under Hatch-Waxman Act

The FDA has announced the availability of a guidance document outlining its application of the 180-day generic drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act following recent court decisions.

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