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TXT Class 1 Recall for LifeScan’s OneTouch Blood Glucose Meter [174 Words] [ Price : $7.95]
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.
04/23/2013
 
 
TXT FDA, CytRx Reach Protocol Agreement on Sarcoma Therapy [536 Words] [ Price : $7.95]
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.
04/23/2013
 
 
TXT Steps Planned for Medical Device Surveillance System [292 Words] [ Price : $7.95]
FDA says CDRH will take several steps in 2013 toward establishing a national medical device postmarket surveillance system.
04/23/2013
 
 
TXT Guidance on Biological Evaluation of Devices [94 Words] [ Price : $7.95]
Federal Register Notice: FDA releases a draft guidance: Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing’
04/23/2013
 
 
TXT IDE Pilot Program Extended [40 Words] [ Price : $7.95]
Federal Register Notice: FDA extends the pilot program for the early feasibility study of investigational device exemption applications.
04/23/2013
 
 
TXT OMB OKs Info on IDE Reports [42 Words] [ Price : $7.95]
Federal Register Notice: The Office of Management and Budget approves a collection of information on investigational device exemptions reports and records.
04/23/2013
 
 
TXT KayPentax Inspection Finds QS Violations [212 Words] [ Price : $7.95]
FDA’s New Jersey District Office warns KayPentax about Quality System regulation violations in its manufacturing of Class 2 medical devices.
04/23/2013
 
 
TXT FDA Draft Guide on Container/Carton Labeling Principles [126 Words] [ Price : $7.95]
A new FDA draft guidance assists prescription drug and biologic product manufacturers on minimizing medication errors by focusing on container and carton labeling aspects.
04/23/2013
 
 
TXT CareFusion Recalls Drug Infusion Pump [261 Words] [ Price : $7.95]
CareFusion recalls its Alaris PC Unit (Model 8015) with Software Version 9.12 drug infusion pump due to communication errors transmitted by the device.
04/23/2013
 
 
TXT FDA Criminal Unit Sees Illegal Internet Pharmacy Owner Sentenced [216 Words] [ Price : $7.95]
An FDA Office of Criminal Investigations case involving an illegal Internet pharmacy leads to a conviction and sentencing for a Florida resident.
04/23/2013
 
 
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