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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.

Goldfish jumping from one bowl into another
Because user-fee deadlines for prescription and generic drugs are approaching, the agency says firms should pay those fees now and ask for a refund after the transition. • 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 Federal Register notice on 6 August that it will not contest the DC Circuit Court...

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