One recent dispute involved the FDA and Halscion, a privately-held company based in Georgia. In 2008, Halscion acquired the license for an injectable hydrogel scaffold—a gel-like structural framework that purportedly promotes fibroblast migration and organization and that had been used for orthopedic applications—with the intent of developing it for improved wound healing of keloid scars (http://bit.ly/205wieB). The combination product initially had been regulated as a device under the jurisdiction of CDRH. But in 2012, the OCP determined that product’s primary mode of action for keloid scar healing was consistent with that of a biological product, placing it under the jurisdiction of CBER. The decision required the company to invest in larger-scale clinical trials to demonstrate adequate safety and substantial evidence of efficacy for this new indication to meet the review criteria for evaluating approvability of a new biological product.