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The EMA’s Committee for Medicinal Products for Human Use recommended seven medicines for approval at its September meeting, including three new drugs, three generics and one orphan drug. Read More
Bipartisan leaders of the House Energy and Commerce Committee sent letters to 16 states asking for details of how they are using federal funds to combat the opioid crisis. Read More
Acting FDA Commissioner Ned Sharpless issued a statement on Friday on the agency’s efforts to increase the availability of naloxone — and to clear up confusion over how the injectable form of the opioid overdose drug can be dispensed. Read More
An online pharmacy petitioned the FDA to recall and suspend the sale of all ranitidine-containing products in the U.S., raising alarms after its tests of the drug detected high levels of NDMA impurities across multiple manufacturers and dosage forms. Read More
A House subcommittee on Thursday heard how some branded drugmakers game the system by reformulating their products solely to block competitors. Read More
House Speaker Nancy Pelosi on Thursday released her much-anticipated drug pricing bill that would allow the government to negotiate drug prices directly with drug manufacturers. Read More
With less than two weeks to go in fiscal 2019, an FDAnews analysis of the FDA’s GMP inspection reports for the year shows that drugmakers continue to stumble at the same old hurdles. Read More