Overview
Before initiating a clinical investigation to study a drug or biologic, review these steps to determine how to comply with Food and Drug Administration (FDA) requirements. This page is intended for UCSF investigators who will initiate their own research protocol and do not have an industry sponsor.
Steps for investigator-initiated drug studies
Step1
Explore whether your study may be exempt from the IND requirement.
Unsure? The UCSF Regulatory Support team can help you determine whether the IRB is likely to agree that your study is IND exempt or requires an IND application. Request a consult external site (opens in a new window) .
Is your study IND exempt?Step2
Consider a Pre-IND meeting with the FDA.
Pre-IND meetings with the FDA can increase the likelihood of a successful IND application.
Pre-IND MeetingsStep3