Regulatory Update: FDA Issues a “Stay” For Parts of the Final Guidance for INDs
In September 2013, the FDA issued Guidance for Clinical Investigators, Sponsors and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND. A stay is currently in effect for parts of subsection VI.D of this guidance. The portions that are stayed are the third paragraph (which pertains to clinical studies intended to evaluate a food’s effect on the structure or function of the body) and a sentence in the fourth paragraph concerning clinical studies intended to evaluate a non-nutritional effect on the structure or function of the body. Clinical investigations intended to evaluate whether a food substance may reduce the risk of a disease in three categories of medically vulnerable subjects (individuals less than 12 months old, those with altered immune systems, and those with serious or life-threatening medical conditions) are excluded from the stay. In Federal Register Notice 80 FR 66907 dated October 30, 2015, the FDA stated that “FDA generally does not intend to seek INDs for studies in the stayed categories while the stay is in effect.” This is good news for makers of dietary supplements and functional foods, as they will be permitted to perform clinical studies without an IND as long as the stay is in effect. Read more in the Federal Register here, and more on the original guidance document and its implications for medical foods regulations in Dr. Laurie Dolan’s article, “Draft Guidelines from FDA for Medical Foods.”