FDA Guidance Documents
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Clinical Research Support is here to help you with FDA compliance.
FDA’s Single Patient IND/IDE Pathway 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.
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.
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.
Cancer Center S-IND/S-IDE WorkflowLearn about the workflow for Cancer Center S-INDs and S-IDEs
FDA Expanded Access InformationExplore the FDA expanded access information page
Physician ResponsibilitiesLearn about the responsibilities of the treating physician
Reagan Udall Expanded Access NavigatorSearch for an Expanded Access contact at a drug or device company