Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND

Guidance for Industry: Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 210KB)

open here please (full-text):
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf