FDA Awards Clearance to W. L. Gore & Associates’ Controlled Expansion for TIPS Procedures March 9, 2017 Physicians can balloon up as needed during implantation to optimize the diameter. Read More
UK Antitrust Regulator Accuses Actavis, Concordia of Delaying Competition to Fix Prices March 9, 2017 Concordia claims the agreement did not breach UK competition law. Read More
AdvaMed Proposes Safe Harbors for Anti-Kickback Statute March 8, 2017 The proposed safe harbors would allow value-based health care arrangements between device manufacturers and buyers. Read More
FDA Proposes Eight-Month Review of Priority Generics, Plans for Wave of Biosimilars March 8, 2017 The FDA is planning to restructure its Office of Regulatory Affairs in May. Read More
BTG Gains CE Mark for Drug-Eluting Bead March 7, 2017 The bead can be loaded with doxorubicin or irinotecan. Read More
White House Planning to Cut Non-Defense Spending by $54 Billion March 7, 2017 White House officials said the full budget proposal will be published in May. Read More
Tryton Medical Gains FDA Approval for Tryton Side Branch Stent March 6, 2017 The device is for patients with large side branch stents. Read More
WHO Releases Draft Update of Stability Testing Guidelines March 6, 2017 Each product must undergo stability tracking throughout its shelf-life to ensure it complies with the label’s specified storage conditions. Read More
India Warns Stent Makers to Supply Products Despite Price Controls March 3, 2017 Stent manufacturers should have issued revised price lists by now. Read More
Tax Court: Mylan Must Deliver Licensing Agreement Docs to the IRS March 3, 2017 In January, IRS officials filed a motion to order Mylan to produce the relevant documents, arguing the company was acting in bad faith. Read More
FDA Awards Clearance to Abbott’s Ablation Catheter March 2, 2017 The device helps collect both electrical current resistance and magnetic data. Read More
FDA Cites Sovereign Pharmaceuticals for Building Failures March 2, 2017 FDA inspectors cited the firm for wall vents that were not operating. Read More