We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA offers its latest advice on what drug sponsors should include when submitting drug master files (DMFs) in a draft guidance released on Friday.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
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
The FDA named Indian drugmaker Torrent Pharmaceuticals as a target of its investigation into nitrosamine impurities and issued the company a warning letter for repeat violations at its Indrad, Gujarat plant. 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
The FDA outlined when sponsors can seek waivers, reductions or refunds of Prescription Drug User Fee Act (PDUFA) fees, in a final guidance released on Wednesday. Read More
Acting FDA Commissioner Ned Sharpless announced that the agency once again approved a record number of generic drugs in fiscal 2019 and flagged upcoming actions to maintain the upward trend. Read More