CTSC Clinical Trials Resource Group: IND and IDE Submissions

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Check out an excellent basic training presentation by the University of Rochester. You will need to create username and password. Make sure to select DOMAIN: Non University of Rochester User.

Orientation to Requirements for FDA Investigational New Drug (IND) Application

Orientation to Medical Devices and the Requirements for an FDA Investigational Device Exemption (IDE) Application

New! FDA Guidances on whether IND/IDE is required

FDA has issued the draft guidance, "IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed."

The document is available on FDA's website: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM328855.pdf

FDA is issuing this guidance to remind institutional review boards (IRBs) of their longstanding role in the review of 1) the qualifications of the clinical investigator, 2) the adequacy of the facility in which the research will take place, and 3) the determination of whether an investigational new drug application (IND) or investigational device exemption (IDE) application is necessary for the proposed clinical investigation.

To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research. This draft guidance document was developed as a part of these efforts and in consultation with OHRP.

Other FDA Guidances on the similar subject:

Contact CTSC Clinical Trial Resource Group for assistance with IND/IDE submissions and communications with the FDA.

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Expanded Access to Investigational Drugs

Expanded Access or compassionate use is the use of investigational drug outside of a clinical trial for the sole purpose of treating a patient or patients with serious or life-threatening disease who have no acceptable medical option. Serious diseases or conditions are those associated with morbidity that has a substantial impact on day-to-day functioning. Whether a disease is serious is a matter of clinical judgment. Examples cited by FDA include epilepsy and in situ breast cancer.

Expanded Access includes three options:
• Treatment IND
• Group C treatment IND
• Emergency Use IND

Download the comprehensive summary here

NEW! 2013 Draft Guidance
Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers:

Who can make a submission for individual patient expanded access when there is an existing IND for the drug?
What are the roles of the patient’s physician and FDA in determining if access for an individual patient is appropriate?
When should individual patient access using the emergency procedures in 21 CFR 312.210(d) be requested?
When can emergency use access begin, when can treatment begin under access INDs not for emergency use, and when can treatment begin under access protocols not for emergency use?

Listen to the FDA Webinar on Expanded Access (February 2010)

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Regulations Affecting Investigational Devices

Participate in a free FDA educational activity entitled, “The Past, Present, and Future of FDA Human Drug Regulation."

If a product is labeled, promoted or used in a manner that meets the definitions in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated as a medical device. A device is:
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,
OR
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Download the comprehensive summary of device classification, regulations, IDE submissions, Humanitarian use designation etc.

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STEP-BY-STEP: Investigational New Drug (IND) and Investigational Device Exemption (IDE)

Introduction

Investigational New Drug (IND)

Investigational Device Exemption (IDE)

As a consequence of increased volume of investigator-initiated clinical research involving drugs and/or devices, there are numerous institutional considerations to ensure that investigators and their research staffs are appropriately equipped to manage all aspects of the regulatory responsibilities and obligations associated with initiating and conducting such research.

The materials on this website are made available by the members of the CTSA IND/IDE taskforce.

1. Investigator Responsibilities inder IND/IDE (Tracy Hysong, CCRP, Regulatory Analyst IV, CTSC)

2. Sponsor and Investigator Responsibility checklist with supporting documents (Partners Human Research Quality Improvement (QI) Program)

3. Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators (M. E. Blair Holbein, PhD, J Inv Medicine (2009), v. 57, n. 6, p. 689-695).

Develop the protocol