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TXT FDA Approves New Boston Scientific Stent System [89 Words] [ Price : $8.95]
Boston Scientific gains FDA approval for the Rebel Platinum Chromium Coronary Stent System.
07/22/2014
 
 
TXT Groups Oppose Antibacterial Drug Trial Changes [470 Words] [ Price : $8.95]
The National Physicians Alliance and Public Citizen tell FDA 10 principles they believe should guide evaluation of new antibacterial drugs.
07/22/2014
 
 
TXT FDA Clears Vascular Pathways Intravascular Catheter [71 Words] [ Price : $8.95]
FDA clears a Vascular Pathways 510(k) for the AccuCath 2.25" Blood Control Intravascular Catheter.
07/22/2014
 
 
TXT FDA Clears Access Pharma’s ProctiGard [98 Words] [ Price : $8.95]
FDA clears an Access Pharmaceuticals 510(k) for ProctiGard and its use in treating rectal mucositis.
07/22/2014
 
 
TXT Comments Sought on FDA Device Statements [56 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on the information collection burden estimate on requests for FDA statements on classification and regulatory requirements for a particular device.
07/22/2014
 
 
TXT Meeting on Biomarker Development [127 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a public meeting 9/5 on approaches to biomarker development.
07/22/2014
 
 
TXT Panel to Discuss BLA for Hypoparathyroidism [84 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 9/12 to discuss an NPS Pharmaceuticals BLA for Natpara for treating hypoparathyroidism.
07/22/2014
 
 
TXT Latest FDA Warning Letters [784 Words] [ Price : $8.95]
In its latest batch of Warning Letters, FDA cites CareFusion Corp., C P Health Products, Home Intensive Care Pharmacy, Noni Connection dba Puna Noni , Oakdell Pharmacy, and RC Compounding Services.
07/22/2014
 
 
TXT ANDA Submission Guidance Changes Sought [261 Words] [ Price : $8.95]
Cornerstone Regulatory’s generic drug clients say there are statements in an FDA draft guidance on ANDA content and format that are not supported or should be changed.
07/22/2014
 
 
TXT QS Violations Found in Carefusion Inspection [397 Words] [ Price : $8.95]
FDA’s Chicago District Office warns Carefusion about Quality Systems and other violations at its Vernon Hills, IL, facility.
07/22/2014
 
 
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