IND Overview and Starting Point
UCSF investigators who will initiate their own research protocol to study a drug/biologic and do not have an industry sponsor should begin here.
Investigational New Drugs and Biologics (IND)
Information for FDA-regulated clinical trials of Investigational New Drugs and Biologics (IND).
Pre-IND Meetings with the FDA
Obtain advice from FDA about your IND study through written correspondence or a meeting.
Prepare an IND Application to FDA
Investigators proposing clinical trials that are not IND exempt (see Overview) should follow these steps to prepare an IND application to FDA.
Maintain Your IND
A Sponsor-Investigator has three types of reporting responsibilities: protocol amendments, safety reporting, and annual reports.
Compilation of IND Resources
Links to the IND resources referenced on all other pages.