FDA Guidance for Industry: Q6B Specifications: Test-Procedures and Acceptance Criteria for Biotechnological/Biological Products
Titel:
FDA Guidance for Industry: Q6B Specifications: Test-Procedures and Acceptance Criteria for Biotechnological/Biological Products
Internet:
Herkunft/Verlag:
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 ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073488.pdf
Dokumentenart:
FDA Guidance for Industry
Inhalt:
Mit dieser Leitlinie sollen einheitliche Standards für die Spezifikationen biologischer und biotechnologischer Produkte definiert werden.