FDA’s MedWatch program announces a Class 1 recall for LifeScan Inc.’s One Touch Verio IQ Blood Glucose Meter because it will fail to provide a warning at extremely high blood-glucose levels.
FDA and CytRx reach an agreement on a special protocol assessment for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas.
Federal Register Notice: FDA releases a draft guidance: Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing’
Federal Register Notice: The Office of Management and Budget approves a collection of information on investigational device exemptions reports and records.
A new FDA draft guidance assists prescription drug and biologic product manufacturers on minimizing medication errors by focusing on container and carton labeling aspects.
CareFusion recalls its Alaris PC Unit (Model 8015) with Software Version 9.12 drug infusion pump due to communication errors transmitted by the device.