FDA Week - 06/07/2019

Court Ruling Against Stem Cell Producer Hands FDA Major Reg Win

By David Roza / June 5, 2019 at 4:14 PM
FDA officials celebrated a decision by a federal judge against a Florida-based stem cell drug manufacturer against which the agency had been seeking a permanent injunction for selling adulterated and misbranded products. The court, by agreeing with FDA that the stem cells were unapproved drugs, handed the agency a major regulatory victory in its effort to oversee the burgeoning field. In a statement the day after the decision on Monday (June 3), Acting FDA Commissioner Ned Sharpless and biologics center...

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