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A key cause of U.S. drug shortages is the market’s failure to reward well-developed quality management systems, according to an analysis by an FDA-led interagency task force released on Tuesday. Read More
An FDA advisory committee voted on Tuesday to support withdrawal of FDA approval for AMAG Pharmaceuticals’ preterm birth injection Makena (hydroxyprogesterone caproate). Read More
Sunrider Manufacturing of Torrance, California drew a Form 483 from the FDA for incomplete complaint investigations and data integrity violations at its OTC manufacturing facility. Read More
Novartis hit three generic drugmakers with a lawsuit in a Delaware federal court for patent infringement over its heart-failure drug Entresto (sacubitril/valsartan). Read More
Allergan announced that its subsidiary Forest Laboratories will pay $750 million to direct purchasers to settle allegations of anticompetitive behavior over the Alzheimer’s drug Namenda (memantine). Read More
Sponsors of CDER-led drug-device combination products that include electronics or software should include specific technical information in their Type V drug master files, the FDA said in a draft guidance released on Monday. Read More