| Q6B Specifications: Test-Procedures and Acceptance Criteria for Biotechnological/Biological Products |
| Short Title: | Q6B |
| Internet: | http://www.fda.gov/cder/guidance/Q6Bfnl.PDF |
| 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/cder/guidance/index.htm |
| 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. |
| Document Type: | FDA Guidance for Industry |