October 8, 2019 / 10:01 PM / 8 days ago

FDA fights Vanda court bid to avoid animal drug study

The U.S. Food and Drug Administration on Tuesday urged a federal judge to reject Vanda Pharmaceuticals Inc’s challenge to its decision to require the company to conduct a study of a drug’s risks to humans using dogs who would be euthanized.

The FDA in a brief filed in federal court in Washington, D.C., said its scientific judgment that Vanda had not provided it enough information to assess the drug’s risks to humans without the new study deserved a “great degree of deference.”

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