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Imaging Drugs Make Jump To Devices In New Decision By FDA

After losing the recent Genus Medical Technologies court case, the US FDA will begin transitioning certain imaging agent drugs to devices. Because user-fee deadlines for drugs and generics are approaching, the agency says firms should pay those fees now and ask for a refund after the transition.

Goldfish jumping from one bowl into another
• Source: Alamy

The US Food and Drug Administration will not contest a recent court decision that concluded radiology contrast agents should be treated as devices and not drugs. The agency says it plans to begin treating a slew of such products as devices, but advises companies to pay their drug and generic user fees now and ask for reimbursement later.

The FDA issued a notice on 6 August that it will not contest the DC Circuit Court of Appeals’ determination that Genus Medical Technologies’ Vanilla SilQ barium sulfate imaging agents should be treated as devices. The agency had argued that it has broad regulatory authority to decide what is a drug versus a device, but the court disagreed

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