Related to FDA Aims to Bridge Communication Gap with Drug Industry During Reviews Through PDUFA V

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• 2-to-1 Majority of Respondents to a GEN Poll See Smooth Sailing Ahead for Vivus' Obesity Therapy
  
• FDA Clears Avid’s Amyloid Plaque Imaging Agent for Aiding Alzheimer Disease Diagnosis
  
• FDA Clears Qiagen’s Rotor-Gene MDx RT-PCR IVD Platform and Influenza Assay
  
• FDA Clears Leica’s Her2 Immunohistochemical Assay on Bond-Max Instrument
  
• Takeda’s Type 2 Diabetes Therapies Set Back Again by FDA
  
• FDA Requests More Risk-Benefit Data for Amgen’s Xgeva sBLA in Prostate Cancer
  
• Novartis’ Afinitor Gets FDA Okay for Treating Renal Angiomyolipoma Associated with TSC
  
• GSK’s Votrient Approved in U.S. for Treating Soft Tissue Sarcoma
  
• Protalix, Pfizer Report FDA Approval of Plant-Derived Gaucher Disease ERT Elelyso
  
• Genzyme Gets FDA, EMA Approvals for Production Plant in Waterford, Ireland
  
• FDA Clears Novo Nordisk’s Levemir for Diabetic Children Aged Two Years and Over
  
• FDA Approves XenoPort, GSK’s Horizant for Managing Postherpetic Neuralgia
  
• FDA Clears Roche’s Perjeta as Combination Therapy for Metastatic Breast Cancer
  
• FDA Clears Immunetics' Rapid Test for Bacterial Contamination of Platelet Units
  
• FDA Approves GSK’s MenHibrix Meningitis Vaccine
  
• FDA Clears Pfizer’s Lyrica for Spinal Cord Injury Neuropathic Pain
  
• FDA Fails to Back Janssen, Bayer’s Xarelto for Acute Coronary Syndrome
  
• BMS, Pfizer Fail to Win FDA Sanction for Stroke Prevention Drug
  
• FDA Clears Baxter’s Gammagard for Multifocal Motor Neuropathy