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...
To view the full article, register now.

UK Financial Services

UK Financial Services

Read Our Latest UK Financial Services Coverage

Financial Services Law360 UK provides breaking news and analysis on the financial sector. Coverage includes UK and European Union policy, enforcement, and litigation involving banks, asset management firms, and other financial services organizations.