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FDA Guidance for Industry: Q6B Specifications: Test-Procedures and Acceptance Criteria for Biotechnological/Biological Products

Origin/Publisher:

Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Document Type:
FDA Guidance for Industry
Content:
This guidance document provides guidance on general principles for the setting and justification of a uniform set of international specifications for biotechnological and biological products.

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