Vanda Pharmaceuticals Inc. is contesting an FDA decision that has placed a “partial clinical hold” on its motion sickness drug Nereus, preventing the company from exploring its use for gastroparesis, a chronic stomach condition. The company’s complaint, filed in the US District Court for the District of Columbia, argues that the reasons provided by the FDA for this hold are unjustified. A partial clinical hold typically suspends certain aspects of a drug’s clinical trials.
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Link to original article source: https://news.bloomberglaw.com/pharma-and-life-sciences/vanda-sues-fda-over-suspended-drug-study-for-stomach-disorder

