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TXT Another Senior Official Drops from FDA Ranks [453 Words] [ Price : $7.95]
In less than a week, a second senior FDA official leaves the agency.
05/03/2013
 
 
TXT Quotient Bio Field Correction on Screening Cells [108 Words] [ Price : $7.95]
Quotient Biodiagnostics initiates a field correction involving one lot of Albacyte Antibody Screening Cells due to labeling issue.
05/03/2013
 
 
TXT FDA Approves Merck’s Liptruzet for Lowering Cholesterol [140 Words] [ Price : $7.95]
FDA approves a Merck NDA for Liptruzet (ezetimibe and atorvastatin) tablets for treating elevated low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia.
05/03/2013
 
 
TXT FDA Classifies Medtronic Correction as Class 1 Recall [198 Words] [ Price : $7.95]
FDA classifies a Medtronic device correction notice on deep brain stimulation lead damage as a Class 1 product recall.
05/03/2013
 
 
TXT Comments Sought on Combination Product Procedure [48 Words] [ Price : $7.95]
Federal Register Notice: FDA seeks comments on a collection of information on the procedure by which applicants obtain designations for combination products.
05/02/2013
 
 
TXT Panel to Discuss Blood Access Devices, Hemoperfusion Systems [125 Words] [ Price : $7.95]
Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel will meet 6/27 to discuss classifying sorbent hemoperfusion systems and implanted blood access devices for hemodialysis.
05/02/2013
 
 
TXT Pilot Program for Field Alert Reports [89 Words] [ Price : $7.95]
Federal Register Notice: FDA announces a pilot program to test an XML-enabled PDF form used to submit NDA and ANDA Field Alert Reports.
05/02/2013
 
 
TXT FDA Gives Orphan Exclusivity to Hyperion’s Ravicti [209 Words] [ Price : $7.95]
FDA grants Hyperion Therapeutics seven years orphan drug exclusivity for Ravicti liquid and its use in treating urea cycle disorder patients.
05/02/2013
 
 
TXT Insulet, Lilly Agree to Develop OmniPod for Humulin Insulin [227 Words] [ Price : $7.95]
Insulet and Eli Lilly enter into an agreement in which Insulet will develop a new version of its OmniPod Insulin Management System that will be designed to deliver Lilly’s Humulin R U-500 insulin.
05/02/2013
 
 
TXT Newport Medical Instruments Recalls Ventilators [198 Words] [ Price : $7.95]
Newport Medical Instruments recalls its HT70 Ventilator and HT70 Plus Ventilator because the devices go into internal backup battery mode sooner than expected.
05/02/2013
 
 
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