FDA WARNING_LETTER - Prodrome Sciences USA, LLC - January 10, 2025

Prodrome Sciences USA, LLC received a Warning Letter from the FDA following an inspection conducted between December 17, 2024, and January 10, 2025. The letter addresses significant violations concerning the company"s clinical investigation (Protocol Pro‐040‐Plasm‐01) of the product ProdromeNeuro™ Oil, which involved 29 human subjects. The primary issue identified was Prodrome Sciences" failure to submit an Investigational New Drug (IND) application before initiating this clinical study. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 312, an IND is required for clinical investigations of products intended as drugs. While Prodrome Sciences argued ProdromeNeuro™ Oil was a dietary supplement, the FDA determined, based on the study design and inclusion criteria for subjects with mild to moderate dementia, that the product was investigated for use in the treatment of a disease, thus classifying it as a drug. The FDA deemed the company"s submitted corrective and preventive action plan inadequate. Prodrome Sciences must provide a more comprehensive response, detailing how they will ascertain when IND regulations apply to future clinical investigations. Furthermore, they need to outline specific procedures for developing and implementing compliance measures for any future studies requiring an IND. This is crucial to ensure the protection of human subjects and adherence to regulatory standards.