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The FDA handed Noven Pharmaceuticals a 13-item Form 483 for lapses in batch reviews and testing, stability and process controls and complaint handling. Read More
The drumbeat for the removal of Bayer’s controversial implantable contraceptive device Essure is growing louder, with a federal lawmaker becoming the latest to urge the FDA to take it off the market until a well-designed study can demonstrate its safety and effectiveness. Read More