This article has been updated with comments from an attorney for Genus Medical Technologies.
Genus Medical Technologies says its barium sulfate product is a device. (Image from Genus Medical Technologies)
A federal judge has temporarily blocked an attempt by the FDA to regulate a barium sulfate product ingested before imaging as a drug.
The decision counts as at least a partial win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body. Judge James Boasberg of U.S. District Court for the District of Columbia on Friday kicked the case back to the FDA for further administrative proceedings.
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Filed Under: Drug Delivery
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