STORY FROM: Drugs & Medical Devices

Zofran MDL Judge Refuses to Bar Bulk of Regulatory Experts’ Opinions

BOSTON — The judge overseeing the federal Zofran birth defect multidistrict litigation docket has refused to bar the testimony of GlaxoSmithKline’s regulatory expert, finding she is qualified to opine that the company properly labeled the anti-nausea drug and “appropriately monitored the drug’s safety in pregnancy.”

In a Nov. 1 order, Judge Dennis Saylor of the U.S. District Court for the District of Massachusetts also refused to exclude the bulk of opinions offered by plaintiffs’ regulatory expert, allowing him to opine that GSK deviated from agency guidance and industry practices by not submitting Japanese animal study results to the FDA and ...

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