Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information

Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information (PDF - 117KB)
September 2010, Posted: 10/14/2010

full-text:

http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM229312.pdf