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U.S. Bioservices will pay $13.4 million to settle a lawsuit concerning allegations the company illegally billed federal and state insurers for prescriptions for Novartis AG’s Exjade in exchange for referrals from the drugmaker, according to a filing from the U.S. Attorney’s Office. Read More
The FDA has agreed to fully share information from its inspections of drug manufacturers with its European Union counterparts, including for the first time trade secrets, the agencies announced. Read More
The European Medicines Agency released a reflection paper to help guide generic drugmakers through the process of setting specifications for in vitro dissolution of immediate-release oral drugs. Read More
The FDA cited a Montreal drugmaker for refusing to allow an FDA inspector to take photographs during an inspection — and said that alone can lead to a finding that products are adulterated. Read More