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Drug manufacturers are making progress toward the FDA’s goal of increasing access to investigational drugs outside clinical trials, the GAO says in a report released Monday. Read More
Trutek has filed suit in a federal court against Matrixx Initiatives, alleging breach of contract and patent infringement by Matrixx’s OTC nasal spray Zicam. Read More
An unregistered outsourcing facility’s failure to report details of more than 4,200 potentially serious adverse events related to compounded hormones drew the ire of CDER Director Janet Woodcock, who reminded outsourcing compounders that they must report serious adverse events to the agency. Read More
Mallinckrodt announced a $30 million settlement with two Ohio counties alleging its subsidiary, SpecGx, had a hand in the nation’s opioid crisis. Read More
A federal appeals court upheld a lower court ruling that Phigenix lacked evidence to prove a patent infringement case against Genentech for the breast cancer drug Kadcyla (ado-trastuzumab emtansine). Read More
Calls for the nomination of acting FDA Commissioner Ned Sharpless to fill the permanent leadership role at the agency continue to grow as the cutoff date for his acting status approaches. Read More