FDA Updates Guide on Live Biotherapeutic Products

An FDA guidance on early clinical trials involving products containing living organisms, such as bacteria, now addresses when the product’s label satisfies chemistry, manufacturing and control (CMC) information requirements.

The announcement from the Food and Drug Administration updates guidance issued in 2012, Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information6 LSLR 201, 2/24/12, 35 BioTech Watch, 2/23/12, 11 MRLR 136, 3/7/12. Live biotherapeutic products are living organisms such as bacteria used for preventing, treating or curing a disease or condition. In addition to the new section on when the label on commercially available products will be considered adequate ...