FDA Guidance for Industry: Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Title:
FDA Guidance for Industry: Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
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 is intended to assist in the establishment of a single set of global specifications for new drug substances and new drug products.