Drugs and Devices

Investigational New Drug (IND) Application

IND Booklet

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 Guidance

Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators – FDA Draft Guidance (2015)
Determining Whether Human Research Studies Can Be Conducted Without an IND – FDA Guidance (2013)
Guidance on Form 3674

FDA Regulation of IND

Investigational New Drug Application: Title 21 Code of Federal Regulations Part 312
Forms and Instructions for IND (FDA)
Guidance on IND Safety Reporting

 

Investigational Device Exemption (IDE)

IDE Booklet

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

Investigational Device Exemptions:  Title 21 Code of Federal Regulations Part 812
“Determining Whether Human Research Studies Can Be Conducted Without an IND” (Draft Guidance from FDA)

Biologics

Vaccines, Blood, and Biologics
FDA Regulation of Biological Products

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

FDA Guidance on Financial Disclosure by Clinical Investigators

FDA Guidance: “Decisions for Investigational Device Exemption (IDE) Clinical Investigations”
FDA Reporting Requirements for IND/ IDE and Biologics
FDA Guidance on Sponsor-Investigator/IRB Interrelationships
Monitoring Guidance for Holders of IDE/IND
“Working with Pharmaceutical Companies on Investigator-Initiated Clinical Trials” (Journal of Clinical Research Best Practices)
Regulatory Documentation for IND Studies
USC IRB Application: IND Questions
USC IRB Application: IDE Questions