FDA Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs
Title:
FDA Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070273.pdf
Content:
This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials