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Zdrowie i gospodarka · 13/08/2001

Draft “Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other Than Blood and Blood Components;” Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other Than Blood and Blood Components," dated August 2001. The draft guidance document provides licensed manufacturers of biological products other than blood and blood components with the agency's current thinking related to the biological product deviation reporting requirements. The draft guidance document will assist the licensed manufacturers of biological products other than blood and blood components in determining when a report is required, who submits the report, the timeframe for reporting, and how to submit the report.

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