User Fee Bill Deems Contrast Agents, OTC Monograph Products As Drugs

House lawmakers’ newly unveiled user fee legislation would ensure FDA regulates certain imaging products, including contrast agents and radioactive drugs, as well as over-the-counter monograph products as drugs and not medical devices, throwing a wrench in FDA’s plan to begin shifting regulation of imaging agents from the drug center to the device center. FDA began the transition after a court ruled the agency could not regulate a specific imaging agent manufactured by Genus Medical Technologies as a drug because it...