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.
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The FDA’s Ophthalmic Devices Panel approved a Class I designation for ophthalmic dispensers, which were reclassified from drugs to devices after the Genus v. FDA decision.
The user fee package was among several health-related bills that the subcommittee took up on Wednesday.
The decision limits US FDA discretion in determining how to regulate products that seem to meet both drug and device standards.