Investigational New Drug (IND)
An IND is an investigational new drug (application). It is a request to the FDA to allow the administration of investigational drugs to humans.
A. Determining if an IND Application is Needed
To determine if an IND is needed for your clinical research or study, complete the IND exemption checklist (found under "IND/IDE").
B. Compiling an IND Application
FDA has set forth the content and format for an IND application in 21 CFR Part 312.23.
To protect researchers and UC, HRPP staff must review IND applications prior to submission to the FDA (per UC HRPP policy III.08) whenever a UC researcher is serving as Sponsor-Investigator (the person who both initiates an FDA
regulated study and has the regulatory responsibility; sponsor in this
roles is not related to funding). Also see definition according to 21 CFR 312.3(b).
If you have questions regarding compiling and maintaining an IND application, please contact Angela Braggs-Brown or Kareemah Mills.
C. IND Application Approval Process
Following submission, the FDA may request additional information or place full or partial clinical holds on the protocol(s) proposed in the IND application. Research cannot begin until all concerns raised by the FDA have been responded to their satisfaction. The FDA will respond within 30 days with an acknowledgement letter including an IND number. This means that the IND has been successfully filed, however, the clinical investigation cannot start until the IRB has granted approval and 30 days after the date of receipt on the FDA acknowledgement letter, unless an earlier notification by FDA is received stating otherwise.
In some cases, the FDA may conclude that the protocol(s) proposed in the IND application is(are) exempt. An exemption means that the study or research may be conducted following IRB approval without an IND application; the investigation(s) must be conducted in compliance with 21 CFR Parts 50 and 56.
D. Maintaining an IND Application
Research must be conducted in compliance with FDA and UC policies and procedures. Researchers must obtain both FDA approval of the IND application, as well as IRB approval of the protocol. All aspects of the study are subject to auditing by the FDA, the UC IRB and its designees.