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TXT FDA Clears Medtronic Signia Stapling System [110 Words] [ Price : $8.95]
FDA clears a Medtronic 510(k) of its Signia Stapling System that enables one-handed staple firing.
02/17/2017
 
 
TXT Fenwal InterSol Slides Mislead on Safety, Efficacy: FDA [2784 Words] [ Price : $8.95]
CBER warns Fenwal about an InterSol slide show that misleads viewers about the drug’s safety and effectiveness.
02/16/2017
 
 
TXT CDER Benefit/Risk ‘Structured Framework’ Explained [2944 Words] [ Price : $8.95]
Three CDER staffers explain the Center’s new structured framework for drug benefit/risk evaluation.
02/16/2017
 
 
TXT Fast Track Status for Axsome Depression Drug Combo [100 Words] [ Price : $8.95]
FDA grants Axsome Therapeutics fast track status for AXS-05 (bupropion and dextromethorphan) for treating treatment-resistant depression.
02/16/2017
 
 
TXT FDA Accepts Biosimilar Submission for Copy of Neulasta [153 Words] [ Price : $8.95]
FDA accepts a Mylan and Biocon BLA for MYL-1401H, a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim), indicated for reducing the duration of neutropenia and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.
02/16/2017
 
 
TXT CDER Considering 101 New and Revised Guidances [2622 Words] [ Price : $8.95]
CDER publishes a 2017 guidance agenda showing plans to publish 101 new and revised guidances in 16 categories.
02/16/2017
 
 
TXT New Data Auditing Process Needed: Consultant [2894 Words] [ Price : $8.95]
Unger Consulting recommends a focused auditing approach to drug quality systems to first ensure that data generated by the systems are trustworthy.
02/16/2017
 
 
TXT Medtronic Cryoablation Catheter Expanded Indication Approved [124 Words] [ Price : $8.95]
FDA approves an expanded indication for Medtronic’s Freezor Xtra Cryoablation Catheter — treating patients with atrioventricular nodal re-entrant tachycardia, a life-threatening abnormal heart rhythm.
02/16/2017
 
 
TXT Marathon Pauses on Duchenne Drug Launch; PhRMA Criticizes [205 Words] [ Price : $8.95]
Faced with a backlash over its $89,000 annual price for a decades-old steroidal drug that was recently approved for treating Duchenne muscular dystrophy, Marathon Pharmaceuticals pauses its “commercialization efforts,” while PhRMA criticizes the original pricing stance.
02/16/2017
 
 
TXT FDA Approves Valeant Pharma NDA for Psoriasis Drug [241 Words] [ Price : $8.95]
FDA approves a Valeant Pharmaceuticals NDA for Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis.
02/16/2017
 
 
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