Drugs & Devices
IND/IDEs
Researchers planning to use a drug or biological product classified by the FDA as an investigational new drug (IND) must assure the IRB they are complying with the FDA’s IND regulations (21CFR312). Researchers planning to use a significant risk device classified by the FDA as an investigational device must assure the IRB they are complying with the FDA’s Investigational Device Exemption (IDE) regulations (21CFR812). Appendix E to the IRB application should be completed for the use of any drug or biological product whether or not it is FDA-approved. Appendix F to the IRB application should be completed for the use of a any device whether or not an IDE is required.
Investigator-Initiated Studies
For all studies in which the sponsor-investigator holds the IND, a protocol should be provided that meets Good Clinical Practice (GCP) guidelines. A template is available at http://www.ctsi.umn.edu/resources/platform/regulatory/indide/home.html. If the sponsor-investigator holds the IDE, a copy of the signed Investigator Agreement should be provided.
IND/IDE Assistance Program
Provided by the Academic Health Center (AHC)
The Academic Health Center (AHC) has annouced the IND/IDE Assistance Program, a new program for faculty investigators who also serve as the sponsor of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA.
Harvey M. Arbit, Pharm.D., M.B.A., will be the director of this new program, which is available to all AHC faculty at no charge. Dr. Arbit has extensive experience in drug development, clinical research, and regulatory affairs at several pharmaceutical companies.
For assistance with preparing new IND or IDE applications or for assistance in maintaining existing INDs and IDEs contact:
Dr. Harvey M. Arbit
Room 507
Children's Rehabilitation Center
612-625-0930
arbit002@umn.edu
Please also visit the:
- University of Minnesota Academic/Administrative Policies:
Labeling Investigational Drugs
Requirements for labeling investigational products are similar to those required for prescription medications. FDA regulations for labeling (21 CFR 312.6) indicate the following:
- The immediate package of an investigational new drug intended for human use shall bear a label with the statement "Caution: New Drug-Limited by Federal (or
United States) law to investigational use."
- The label or labeling of an investigational new drug shall not bear any statement
that is false or misleading in any particular and shall not represent that the
investigational new drug is safe or effective for the purposes for which it is being
investigated.
In addition, state regulations for labeling prescription drugs apply to investigational drugs (see Minnesota Statutes 151.06 subd 1, 151.212 subd 1):
All drugs dispensed to or for a patient (other than an inpatient of a hospital) shall be labeled with the following:
- Name, address and telephone number of clinic dispensing
- Subject's name or identifying number
- Prescription number, or way of tracking the dispensing
- Name of prescribing physician
- Directions for use
- Name of manufacturer of the finished dosage form (there may be an exception due to investigational status)
- Auxiliary labels as needed, e.g. "Take on empty stomach."
- Date of original issue or renewal
- Generic or trade name of drug and strength or study name to identify drug
There may be some flexibility allowed for labeling due to the unique nature of investigational studies, particularly studies involving a placebo.
Sample label:
Univ of MN Clinic Name
Address, Phone number |
|
|
|
Tracking Number (ie visit number)
Subject ID (name or initials) |
Date of issue:
Prescribing MD, or PI if MD |
Drug name and strength or study acronym |
(Manufacturer) |
|
|
Directions for use. |
|
|
Humanitarian Device Exemptions (HDEs)
A Humanitarian Use Device (HUD) is a medical device that has been granted a special exemption by the FDA known as a Humanitarian Device Exemption (HDE). The expected market for HUDs is so small that studies needed for full FDA approval would never be able to be carried out. Researchers wishing to use an HUD should complete the Health & Biological/Medical application form found on the IRB’s Web site at
The application should describe the researcher’s interest in using the device and the instances in which it will be used, specifying that the intended use is within the scope of the HDE. The study title should include the designation “HDE” and/or “HUD”.
A research consent form should be included. This consent form should make clear that the researcher believes this device might work better than standard therapy but that it has not been tested in the usual way for full FDA approval the way most devices are since its use is rare. Studies using HUDs are reviewed by the full IRB committee.
Other Related Documents
|
