Drugs, Devices, and Biologics
Investigational New Drug (IND) Application
An IND application is the document submitted to the Food and Drug Administration (FDA) for permission to conduct a clinical study using a drug that is new or not approved for that dosage, form, or indication.
Determining if an IND Application is needed
Ask yourself if the investigational drug:
- is for a product intended to be submitted to FDA by the “sponsor-investigator” in support of a new indication for use or for a significant change in labeling of drug
- is for a product intended to support a significant change in advertising (i.e., for use in children as well as adults)
- involves a different route of administration or dosage level or use in a new, high-risk, and/or different patient population or other factor that significantly increases the risks associated with use of the product – or decreases the acceptability of the risks
If you answered yes to any of these questions, then you will need to apply for an IND application.
Preparing an IND Application
The documents needed to prepare an IND include:
- Form FDA 1571 (IND Application) or a dossier addressing all of the elements outlined in Form 1571 is submitted by the sponsor or sponsor-investigator.
- Form FDA 1572 (Statement of Investigator)
- Form FDA 3674 (Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank)
FDA Regulation of IND
Investigational Device Exemption (IDE)
An Investigational Device Exemption (IDE) application is the document submitted to FDA to allow for the conduct of a clinical study using a significant risk device that is new or not approved for that use.
Determining if an IDE Application is needed
- Significant risk devices: An IDE is required to study an investigational device (including new intended use of an approved device) posing significant risk* and must be submitted to FDA before study initiation.
Significant risk: presents a potential serious risk to the health, safety, or welfare of subject (e.g., stents, sutures)
- Non-significant risk devices: If the investigation involves the use of a device that does not pose significant risk to humans (a non-significant risk* device), an IDE application to FDA is not required. Submissions for non-significant risk devices are made directly to the IRB. The sponsor-investigator must explain to the IRB why the device does not pose a significant risk.
- IDE Exempt Investigation: The FDA may determine that your study is exempt from FDA regulation. However, the study is still subject to IRB regulation. (List of exemptions can be found HERE.
FDA Regulation of IDE
Biologics
Complying with USC Educational Requirments
In addition to federal and state requirements, USC IND or IDE holders must comply with applicable USC educational training requirements.
Human Subjects Education On-line
All investigators and key personnel conducting human subjects research at USC, whether IND/IDE holders or not, must complete the CITI human subjects education. The mandatory training is a condition of IRB study approval. The education is available online.
CITI FAQs
| citiprogram.org
Good Clinical Practice (GCP)
Good Clinical Practice training is required for all principal investigators and key personnel conducting full board clinical trials (not applicable to personnel who conduct expedited or exempt studies exclusively).
GCP FAQs
HIPAA
All USC faculty, staff, employees, students, volunteers and agents with access to patient protected health information (PHI) from USC providers must complete the online HIPAA compliance program.
Additional Resources
