The US Food and Drug Administration succeeded in getting Congress to undo a court ruling that prompted the agency to start transitioning certain products regulated as drugs to device status. The omnibus government funding legislation that cleared Congress at the end of December included a rider specifying that “any contrast agent, radioactive drug, or OTC monograph drug shall be deemed to be a drug” and not a “device.”
As a result, the upheaval in this space will be averted and regulation of these products will go back to...
