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Regulatory Support

We provide regulatory support, guidance and education to the UTHSC research community. 

We primarily serve investigators whose research may require an IND/IDE application to the US Food and Drug Administration.  

Our office assists investigators in determining if their human research study using a drug or device may qualify for an exemption and not require an IND or IDE application. Exempt studies require IRB oversight, regardless of the exemption. Services include:

  • IND exemption-determination (TN-CTSI IND Checklist)
  • IDE exemption-determination (TN-CTSI IDE Checklist)
  • Assistance with IND/IDE submissions
  • Assistance in fulfilling regulatory responsibilities
  • Education and training for FDA regulated studies
  • Centralized resource for registration and result reporting to clinicaltrials.gov
  • Assistance with the creation of a Data Safety Monitoring Board (DSMB)
  • Assistance with commercialization of UT intellectual property (UT Research Foundation)

 

KEY DEFINITIONS

Investigational New Drug Application (IND)
A request from a clinical study sponsor to obtain authorization from the FDA to administer an investigational drug or biologic to humans. Approval of an IND application by the FDA allows interstate shipment and administration of any new drug or biologic that has not yet been approved.
Investigational Device Exemption (IDE)
Allows the investigational device to be used in a clinical study in order to collect safety and efficacy data. Investigations covered under the IDE regulation are subject to differing levels of regulatory control depending upon the level of risk.  The IDE regulation distinguishes between significant and nonsignificant risk studies and procedures
Sponsor
The person or entity who takes responsibility for and initiates the clinical research study.  The sponsor may be the investigator, academic institution, pharmaceutical company, governmental agency, or public or other organization.  
Investigator-Sponsor
An individual who both initiates and conducts the clinical research study under which the investigational drug is administered or dispensed.
Investigator-Initiated IND 
An IND submitted by an investigator who both initiates and conducts a clinical research study.
Emergency Use IND 
An IND issued by the FDA to allow the use of an experimental drug or biologic for the treatment of one patient when there are no other reasonable treatment options and there is not time for submission and review of a regular IND or for full IRB review. Investigators pursuing emergency use authorization from the FDA should review the UTHSC IRB SOP (UTHSC IRB Emergency Use SOP). An emergency use IND may be used one time only for a particular drug or biologic at a particular institution.  Subsequent uses require prior IRB review and approval.
Expanded Access (Compassionate Use) to Unapproved Drugs for Treatment

Allows certain individuals not enrolled in clinical trials to obtain expanded access to investigational drug or biologics in certain circumstances. Physicians pursuing expanded access to an unapproved drug should review the UTHSC IRB SOP (UTHSC IRB Compassionate/Treatment Use SOP). Although expanded access is a form of clinical care, it is performed under IND regulations and is therefore subject to IRB review.

  • Patients have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to treat the disease
  • Potential patient benefit justifies the potential risks of the treatment 
  • Providing the investigational drug will not interfere with clinical investigation that could support approval
Exempt IND Clinical Investigation 

Involves study of a drug that is lawfully marketed in the United States, is not intended to support a new indication or a change in the drug labeling or drug advertising, does not use a dose level, route of administration, nor patient population that significantly increases the risk of the drug, and the study is reviewed by an IRB.

LINKS, TEMPLATES, FORMS, TRAINING

 
(ND Initial Submission, IND Cover Letter, IND Annual Report, IND Final Report, IDE Initial Submission, IDE Progress Report)
(1571, 1572, 3674, 3455 Financial Disclosure, 3454 Financial Disclosure)
WHEN IS AN IND REQUIRED?
An IND is required for 1) clinical studies when a drug or biologic is not approved for marketing by the FDA, 2) studies involving an approved drug or biologic seeking a new indication or a significant change in labeling, 3) studies involving an approved drug or biologic seeking a new route of administration, new patient population, or new dosage level, or 4) any use of a drug or biologic not approved by the FDA even if no study is being conducted.
WHEN IS AN IDE REQUIRED?
An IDE is required for 1) clinical studies involving an unapproved device that poses significant risk to subjects and 2) clinical studies involving an approved device being tested for a new indication. Many in vitro diagnostic (IVD) devices are exempt from the IDE regulation. Exempt IVD devices include diagnostic devices that are noninvasive, do not require an invasive sampling procedure that presents significant risk; does not by design or intention introduce energy into a subject; and is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure. Studies which are exempt from the requirements of the IDE regulations are not exempt from the requirements for IRB review and approval and the requirements for informed consent.
INVESTIGATOR RESOURCES
The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) is an additional resource for investigators providing regulatory tools and resources necessary to successfully navigate the regulatory process from discovery to the implementation of clinical trials of new drugs, biologics, and medical devices. Training and educational events regarding regulatory guidance are also available at the ReGARDD website.
Apr 27, 2023