Amgen Hit With FDA Warning Over Drug-Device Combos

Law360, New York (February 11, 2014, 8:02 PM EST) -- The U.S. Food and Drug Administration on Tuesday released warning letters chastising Amgen Inc. for alleged design shortcomings related to prefilled syringes and Baxter Healthcare Corp. for the way it responded to complaints about certain medical devices.

In the letter to Amgen, regulators focused on syringes of osteoporosis drug Prolia and arthritis drug Enbrel, as well as vials of Enbrel with so-called vial adapters. One problem uncovered during a June inspection was that Amgen started sales of Prolia in 2010 before carrying out so-called design validation procedures that are intended to ensure a product was manufactured in accordance with its specifications, the...

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