FDA Guidance Documents
Search guidance documents published on the FDA website
The IND/IDE Office will help you with FDA compliance
FDA Guidance Documents
Search guidance documents published on the FDA website
FDA’s Single Patient IND/IDE Pathway (for investigational new drugs and devices) allows use of an investigational drug, biologic, or device to treat a patient who:
We can help treating physicians navigate this pathway for their patients who meet these criteria. We will facilitate the FDA application process, IRB Chair Review request, and institutional reviews. However, the treating physician will be the IND/IDE holder, and must comply with all regulatory, institutional, and manufacturer requirements in order to treat a patient under a single patient IND/IDE.
A research IND (also called a non-commercial IND) is one for which the sponsor (generally an individual investigator, academic institution or non-profit entity) does not intend to later commercialize the product. These studies are
strictly for research, are usually shorter in duration and may result in publications in peer-reviewed journals. In comparison, a commercial IND is one for which the sponsor (usually a corporate entity) intends to commercialize the product by eventually
submitting a marketing application.
For more information on developing an IND/IDE review the details on the IND/IDE webpage and complete the triage form.
All communications with the FDA now go through the IND/IDE program. They will be happy to engage and assist you to support your IND or IDE application.
Cancer Center S-IND/S-IDE Workflow
Learn about the workflow for Cancer Center S-INDs and S-IDEsFDA Expanded Access Information
Explore the FDA expanded access information pagePhysician Responsibilities
Learn about the responsibilities of the treating physicianReagan Udall Expanded Access Navigator
Search for an Expanded Access contact at a drug or device company