Federal Register
Notice: FDA is making available Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components. The guidance document provides licensed manufacturers of biological products other than blood and blood components with the FDA's current thinking related to the biological product deviation reporting requirements. This guidance finalizes the 8/01 draft guidance document of the same title. To download this guidance, click here. To view this notice, click here.