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Zdrowie i gospodarka · 11/02/2009

FDA Approves New Animal Drug Application for Genetically Engineered Goats Producing Human Antithrombin

The FDA is amending its regulations to reflect the approval of a new animal drug application filed by GTC Biotherapeutics, Inc. for genetically engineered goats producing human antithrombin, a biological product for human therapeutic use, which has also been approved for human use through a separate biologics license application.

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