An Investigational New Drug (IND) application is required before your product can be studied in a clinical trial for a medical outcome. The IND application presents a case to the FDA arguing that your product is safe for use on human subjects and is reasonably expected to offer a benefit. This is accomplished through a comprehensive and lengthy application which compiles all of the existing evidence on the ingredients, including laboratory tests, animal testing, manufacturing procedures, and history of human use. The IND also requires a proposed research study so that the FDA can confirm its suitability.
It is a violation of the FDA’s Food, Drug, and Cosmetic Act to ship an unapproved drug in interstate commerce (21 U.S.C. § 355(a)). The IND provides authorization to ship the unapproved new drug to human subjects, participating medical centers, and clinical researchers for clinical research purposes.
Not all nutraceuticals require an IND for clinical research. If the outcome is related to a structure and function claim, an IND is not required. INDs are exclusive to drug testing. The distinguishing factor is not the product or formulation, rather the outcome being evaluated. If the outcome is a drug claim, an IND is required; if the outcome is a S/F claim, no IND is required.
A complete IND is a lengthy document, which requires interdisciplinary expertise. Incomplete INDs can result in costly delays to the research process, lengthening the timeline between development and drug approval. Our team of experts can compile portions of the IND or the entire IND application for your proposed studies, depending on your company’s needs.