Page Updated: 05/09/03

The Food and Drug Administration (FDA) is an agency within the U.S Department of Health and Human Services (DHHS) responsible for regulating human subjects research --conducted in the U.S. or funded in part with U.S. federal funds-- involving investigational drugs, biologics, and medical devices. In the U.S., only drugs whose safety and effectiveness in humans are assured receive FDA-approval for their sale in the marketplace.

Sponsors or investigator sponsors wishing to conduct clinical research with an investigational drug, biologic or device must file and Investigational New Drug application or an Investigation Device Exemption application with the FDA before commencing their research. "An IND is a request for FDA authorization to administer an investigational drug to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug that is not the subject of an approved new drug application." (from Information for sponsor-investigators submitting investigational new drug applications (INDs)

  • www.fda.gov/cder/forms/1571-1572-help.html

    A clinical study involves "investigational" use of a drug or device if

      (i) the drug/device does not have FDA-approval, or

      (ii) the drug has FDA-approval but it will be used in an "investigational" way in the clinical study. The use of an FDA-approved drug is considered investigational when (a) its use is different from the FDA-approved use and (b) it poses an increased risk. (see 21 CFR 312.2(b)(1) - for link go to ethics codes and regulations page).

    For researchers/sponsors subject to U.S. FDA regulations:
    • If you plan in your human subjects study to use an FDA approved drug, but you propose an "off-label" or investigational use of the product, then you will need to file an IND.

    • If you plan in your human subjects study to use a product (including a shelf-chemical) that does not have FDA approval, then you should file an IND application.
    At the FDA links listed below, you will find details regarding IND/IDE applications:

    Investigational New Drug Application Process - Visit this site for an introduction and discussion of the IND application process. Topics addressed include: types of INDs, information the IND application must contain, resources for IND applications, guidance documents for INDs, laws, regulations, policies and procedures, IND forms and instructions.

  • www.fda.gov/cder/regulatory/applications/ind_page_1.htm

    Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs) - Here you will find instructions on how to properly complete the IND application (FDA Forms 1571 and 1572).

  • www.fda.gov/cder/forms/1571-1572-help.html

    FDA Information sheet: "Off-Label" and Investigation Use of Marketed Drugs, Biologics, and Medical Devices," Guidance for IRBS and Clinical investigators. - This information sheet identifies criteria which exempt a sponsor/investigator from filing an IND application.

  • www.fda.gov/oc/ohrt/irbs/offlabel.html

    Frequently Asked Questions on Investigational New Drug Applications

  • http://www.fda.gov/cder/about/smallbiz/faq.htm

    Good Clinical Practice in FDA-regulated Clinical Trials - "These guidances and information sheets represent the Agency's current guidance on good clinical practice and the conduct of clinical trials."

  • www.fda.gov/oc/gcp/guidance.html

    FDA "A Guide to Informed Consent" - Guidance for IRBs and Clinical Investigators.

  • www.fda.gov/oc/ohrt/irbs/informedconsent.html