An Investigational New Drug (IND) application is required when a drug is involved in a human clinical investigation that is not deemed exempt (21 CFR 312). Food and Drug Administration (FDA) approved drugs can be used in studies and sometimes FDA can issue a waiver. The FDA provides guidance regarding what studies qualify for exemption. However, the guidance is sometimes difficult to interpret. There are shades of gray in the interpretation and there are often differences in opinion among federal agencies. There are many questions surrounding the use of dietary supplements and food products in research.
The UK Center for Clinical and Translational Science (CCTS) has established the CCTS FDA Advisory Committee to assist investigators in navigating the FDA submission process. This committee is a multidisciplinary team of individuals that have clinical research expertise and prior experience interacting with the Food and Drug Administration (FDA). The committee is advisory in nature and will assist investigators in assessing the need for an IND or IDE, provide guidance regarding the best study design, use of resources and assist in responding to the FDA . The CCTS can provide regulatory support to assist investigators with the FDA IND/IDE submission process if needed. To request a review by the committee please submit a service request form.
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IND Application Procedures: Exemptions from IND Requirements
Frequently Asked Questions on Botanical Drug Product Development
William Stoops, PhD
- Director, Regulatory Knowledge and Support Core
- (859) 257-5388