Drugs and Devices

 

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), or
  • 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 must be 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.

FDA Regulation of IDE

Biologics

Complying with USC Educational Requirements

In addition to federal and state requirements, USC IND or IDE holders must comply with applicable USC educational training requirements.

Additional Resources