FDA Guidance Documents
Search guidance documents published on the FDA website
FDA Submission Support
Clinical Research Support is here to help you with FDA compliance.
FDA Resources
Submissions
FDA’s Single Patient IND/IDE Pathway allows use of an investigational drug, biologic, or device to treat a patient who:
- Is suffering from a serious or immediately life-threatening disease or condition, and
- Does not have comparable satisfactory alternative therapies, and
- Cannot participate in a clinical trial.
- If the risks associated with treatment are not unreasonable, and potential benefit justifies potential risks.
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.
Submit to the Patient IND/IDE Portal
1
Fill this out ONLY if you have been prompted to do so by a Clinical Research Support team member
2
If you need to save and return later, SAVE YOUR RETURN CODE
3
Once you have submitted, DOWNLOAD A PDF COPY OF YOUR SUBMISSION.
You will need it for IRB Chair Review
FDA's NextGen portal may be used to electronically submit CDER (not CBER) research INDs:
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.
The NextGen portal can be used to submit initial IND applications, amendments, supplements, reports, and master files (MF), as well as for requesting an IND number.
Please follow the CDER NextGen Portal Supplementary Instructions for CU Submitters.
Submit to the NextGen Portal
Contact Us
Has the FDA notified you they will be coming for an inspection of your site? Do you need to treat a patient under a Single Patient IND/IDE? We can help you prepare.
Helpful Resources
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