Overview
If a planned clinical trial of a drug or biologic does not qualify for an IND exemption, the investigator should follow the steps below to prepare an IND application for submission to the FDA.
The UCSF Regulatory Support team can help you determine whether an optional pre-IND meeting would be helpful, or if you should proceed with preparing an IND application.
Step1
Draft the IND Study Protocol
A fully developed clinical protocol is the basis for both the IRB application and the initial IND submission to the FDA.
Draft Your IND Study ProtocolStep2
Prepare the Initial IND Application Components
A complete IND application includes eight components.
Incorporate all Eight IND Application ComponentsStep3