Getting combinations right

Advocates for restructuring FDA around major diseases have received a boost from Vice President Joe Biden's cancer "moonshot" initiative, and from decades-old efforts to overhaul the regulation of products that include components that fall under the jurisdiction of more than one of FDA's medical product centers.

The goals include more closely integrating the regulation of companion diagnostics and the drugs that depend on them, as well as reducing the regulatory burden for low-risk devices that could be classified as drugs or biologics. ...