Genus Triumphs Over FDA In Barium Sulfate Product Classification Suit
Executive Summary
The decision limits US FDA discretion in determining how to regulate products that seem to meet both drug and device standards.
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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.
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.
Financial Penalties, COVID-19 Liability Top FDLI List Of Top Medtech Lawsuits
The report outlines the lawsuits that the Food and Drug Law Institute believes could have the greatest impacts on industries regulated by the US FDA.