Processing Treatment INDs and Treatment Protocols

Manual of Policies and Procedures (MAPP) 6030.6 (PDF - 164KB) INDs: Processing Treatment INDs and Treatment Protocols
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM283082.pdf