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.