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

By Beth Wang / May 6, 2022 at 6:21 PM
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...

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