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JPN_1

  1. PDUFA Clears Senate With Few Changes, House to Vote Next Week: The Senate overwhelmingly approved the omnibus F... bit.ly/LNvBxQ
  2. UK Devicemaker Warned by FDA on Documentation, Production bit.ly/KYleoK
  3. Panel Debates Risk Categorization, Surveys for Weight Loss Devices bit.ly/MxemAd
  4. Arcalyst’s sBLA Review Shows Need for Attention to Target Population: Safety and efficacy data for Regeneron’s ... bit.ly/KlW2tj
  5. Another German drugmaker, Riemser Arzneimittel, on the block bit.ly/KHbnUj
  6. ANDA Reviews Bogged Down By Missing, Buried Compliance Data: FDA Officials: Generic-drug makers are contributin... bit.ly/MqoDye
  7. Naming Challenges lnkd.in/cKyBni
  8. FCC Aims to Broaden Spectrum Used by Wireless Medical Devices bit.ly/MpVao7
  9. NICE nod for Xarelto as FDA panel mulls new use bit.ly/KdVqpp
  10. Timely PDUFA Passage Uncertain as Senate Debate Continues, But Vote Could Come This Week: The timely passage of... bit.ly/KdybMl
  11. FDA Warns Against Untested MS Treatment, Calls for Rigorous Studies bit.ly/JEThWB
  12. Private equity owner seeks $510M-plus deal for Germany's Aenova bit.ly/KjPpbv
  13. J&J Unit Tweaks Packaging Line After Imodium Recall: Johnson & Johnson (J&J) subsidiary McNeil Consumer Health... bit.ly/KtF6jz
  14. FDA Increasing Role in Quality Promotion for Devicemakers, CDRH Official Says bit.ly/K5Czg0
  15. EU-Style Device Approval Poses Patient Safety Risks, FDA Says bit.ly/LlwBf8
  16. Novartis Sees Positive Phase III Data for COPD Candidate: Novartis’ chronic obstructive pulmonary disease (COPD... bit.ly/KKtSJR
  17. Senate Updates PDUFA V Language, Plans Vote for Next Week: The Senate plans to debate and vote on an omnibus FD... bit.ly/JTgjGY
  18. Medicare DME Savings Exact Toll on Suppliers, Access to Care bit.ly/KdCSoc
  19. Study Urges Flexibility in Quality Testing of FDA-Approved Drugs Launching in Developing Countries: Drugmakers... bit.ly/JgfUAk
  20. FREE tickets to Shakespeare's MACBETH for May 29th at 6pm (includes finger food and wine in the interval) for details meetu.ps/bKqxg