February 24, 2012
FDA’s Center for Biologic Evaluation and Research (CBER) issued a finalized guidance for industry on when an Investigational New Drug (IND) application is required for human research on live biotherapuetic agents. The draft guidance on a similar topic issued by CBER and the Center for Drug Evaluation and Research (CDER) October 2010 has not been finalized. This final guidance acknowledges that live microbes (probiotics) intended for use as foods or dietary supplements can be investigated with human studies without an IND. The new guidance falls short of acknowledging an IND-free research path for human studies on medical foods, foods for special dietary uses or to research a food Health Claim. Foods or dietary supplements being studied for drug purposes (cure, mitigate, treat, diagnose, or prevent disease) will require an IND.