October 30, 2015
In response to stakeholder comments, the U.S. Food and Drug Administration is staying select parts of a final guidance on Investigational New Drug (IND) applications. The guidance, which was finalized in 2013, was issued to clarify when researchers or sponsors need to file IND applications prior to conducting human research studies.
Specifically, the agency is staying parts of the subsection on conventional foods, and all of the subsection on studies intended to support health claims, with one exception: the stay of the health claim subsection does not apply to clinical studies that include children under a year of age, people with altered immune systems, or people with serious or life-threatening medical conditions.
While the partial stay is in effect, researchers and sponsors of studies that are intended to support a new or expanded health claim and conducted in healthy individuals over 12 months of age do not need to obtain an IND. Similarly, researchers and sponsors of studies of non-nutritional effects of conventional foods on the structure or function of the body do not need to obtain an IND while the stay is in effect.
The partial stay will serve to encourage scientific research into the relationship between diet and health while FDA considers comments received in response to the final guidance.
The FDA has also republished the final guidance with the stayed portions clearly identified to prevent confusion about which parts of the guidance are stayed and which are still in effect.
For more information: ·
- Federal Register Notice
- Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND