J&J, Medtronic Knock TGA’s Device Review Plan June 21, 2017 Companies say plan could exclude technologies with limited data. Read More
FDA Publishes Case Studies on Biomarker Qualification June 21, 2017 Two fictional case studies highlight the role of biomarker qualification in research. Read More
India to Open $6 Million Medical Device 3D Printing Facility June 20, 2017 Indian government aims to increase domestic device production. Read More
EMA Postpones Clinical Trials Regulation, Expects Relocation Decision by October June 20, 2017 The EMA postpones its Clinical Trials Regulation to 2019 due to IT issues. Read More
One in Three Heart Surgery Temperature Control Devices May Be Contaminated June 19, 2017 Major device manufacturer to modify design, offer free deep infection service. Read More
TGA Expands Drug-Tampering Recalls to Arrow, Sandoz June 19, 2017 Blister sheets of other drugs may have been packaged with generic Valium. Read More
Abbott’s Alinity Hq Analyzer for Hematology Wins CE Mark June 16, 2017 The Alinity hq analyzer automates the performance of these tests and reports on 29 different parameters. Read More
FDA Warns A-S Medication Solutions for Inaccurate Drug Listings June 16, 2017 These errors put the company in violation of 21 CFR Part 207. Read More
OBP Medical Gains Sure-Scope Regulatory Approval in Australia June 15, 2017 Sure-Scope is a disposable, one-piece laryngoscope with integrated LED light source. Read More
One In, Two Out Executive Order Will Likely Increase Use of Internal FDA Communications June 15, 2017 Much of the agency’s policymaking is done through clarification rather than new regulations. Read More
FDA Grants Clearance to QT Ultrasound for Breast Imaging Device June 14, 2017 The breast scanner is not intended as a replacement for screening mammography. Read More
TGA Plans to Allow Automatic, Instant Approvals of Lowest-Risk Product Variations June 14, 2017 The industry requests will be characterized as notifications. Read More