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The FDA offers its latest advice on what drug sponsors should include when submitting drug master files (DMFs) in a draft guidance released on Friday. Read More
The federal judge at the center of the first opioid bellwether trial met with key litigants on Friday to hammer out a settlement, but the eleventh-hour effort stalled. Read More
The new law presumes that “these agreements are anti-competitive and delay the entry of the generic drug into the market place,” notes the state’s Attorney General Xavier Becerra. Read More
Most enacted drug transparency laws are flawed because they don’t require the release of transaction prices at each stage of the pharmaceutical distribution process, according to researchers at the University of Southern California. Read More
In a vote on Thursday along mostly party lines, the House Committee on Education and Labor advanced the Lower Drug Costs Now Act of 2019 (H.R. 3) with an amendment that would empower HHS to negotiate with drugmakers on prices for more prescription drugs. Read More