FDA Stands Firm: Clinical Trials Exploring Structure/Function Effects Need IND
This article was originally published in The Rose Sheet
Executive Summary
Despite industry's assertion that FDA is unlawfully reinterpreting statutory definitions under the Federal Food, Drug and Cosmetic Act, the agency's republished final guidance maintains that cosmetics evaluated for structure/function effects in clinical trials require Investigational New Drug go-ahead before being transported from one state to another. Anti-aging skin- and hair-care research could be impacted most.