The Quality Improvement Office partners with Indiana CTSI to provide education and tools to help Indiana University investigators who are conducting research with drugs, biological products or devices regulated by the Food and Drug Administration (FDA). This includes education and support for investigators who hold an IND or IDE.
When is an IND required?
- Most investigations of drugs or biological products require submission of an Investigational New Drug Application (IND) to the FDA.
- If the study involves a drug used in humans in any way other than in the course of medical practice, an IND is required unless certain exemptions apply.
- Exemptions are some investigations of already approved drugs, some studies using diagnostic biological products and in vitro drug tests, and some bioavailability or bioequivalence studies
- For additional background see 21 CFR § 312.2. A study that is exempt from the IND requirement must still comply with FDA requirements for IRB review (21 CFR § 56) and informed consent (21 CFR § 50).
When is an IDE required?
- When the principal intent of the medical device (or other product regulated as a device) is to develop information about the product's safety or efficacy, submission of an Investigational Device Exemption application (IDE) is ordinarily required.
- However, in certain circumstances, the FDA does not require an IDE.
- Investigations of devices fall into one of three categories: exempt from IDE requirements, studies of nonsignificant risk (NSR) devices subject to abbreviated IDE requirements, or significant risk (SR) devices subject to full IDE requirements.
- A study that is exempt from the IDE requirement must comply with FDA requirements for IRB review (21 CFR § 56) and informed consent (21 CFR § 50).
Who to contact for assistance
Responsibilities of holding an IND or IDE
Links to FDA forms/regulations/guidance documents:
- There are a variety of topics to choose from, some are very specific to therapeutic areas, others are general
- QIO recommends the following to stay abreast of important FDA related information
- Guidance Documents
- FDA Warning Letters (Within “Regulations, Laws and Standards” section)
- Good Clinical Practice (Within “Regulations, Laws and Standards section)