Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Review: Aleve Safer Than Other NSAIDS, Labeling Should be Changed (2

Regulatory Reconnaissance: FDA Review: Aleve Safer Than Other NSAIDS, Labeling Should be Changed (29 January 2014)

Posted 29 January 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

  • EU, UK evaluating FDA findings on Ranbaxy's Toansa facility (India Times)
  • India Drug Regulator Vows Surprise Inspections For All Drug Makers (PharmAsia-$)
  • Ranbaxy Execs Called On DCGI Carpet To Explain Drug-Making Problems (PharmAsia-$)
  • China's pharma blacklist could be weakened by inconsistent enforcement (Pharma Letter-$)
  • Canada approves infliximab biosimilar (BioCentury)

US: Pharmaceuticals/Biotechnology

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

US: Medical Devices

  • Health app makers face privacy and security regulation from many quarters (MobiHealthNews)
  • FDA Sends Rare Warning Letter to Mammography Facility (FDA)
  • Benvenue notches FDA nod for spinal-repair device (Fierce)
  • Atheromed Gains FDA Approval for Phoenix Atherectomy Device (MedGadget)
  • Kiva VCF Now Cleared in U.S. as New Option for Treatment of Vertebral Compression Fractures (MedGadget)
  • Calif. Court Reverses Preemption Of Medtronic Injury Suit (Law 360-$)
  • Judge allows Riata lawsuits to move forward (Cardiovasvcular Business)

US: Dietary Supplements

  • Hydroxycut False Ad Claims Must Be Clarified, Judge Says (Law 360-$)

US: Assorted And Government

  • Pharma companies differ on Sunshine Act payment definition (PMLive)
  • SOTU: Research, trade & Obamacare among Obama's 'ladders of opportunity' (SCRIP-$)
  • DARPA awards cooperative agreement to assess mechanisms of drugs and chemical agents (Press)

Upcoming Meetings And Events

  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 29-30 January 2014: Science Advisory Board to the National Center for Toxicological Research Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU, UK evaluating FDA findings on Ranbaxy's Toansa facility (India Times)
  • OctreoPharm Sciences GmbH Receives EMA Orphan Drug Designation for OPS202 (SOMscan), a next generation antagonistic peptide for the Management of Neuroendocrine Tumors (Press)

India

  • India Drug Regulator Vows Surprise Inspections For All Drug Makers (PharmAsia-$)
  • Ranbaxy Execs Called On DCGI Carpet To Explain Drug-Making Problems (PharmAsia-$)
  • Ranbaxy plant at Toansa under UK and Aussie regulators' inspection (India Times)

Japan & China

  • China's pharma blacklist could be weakened by inconsistent enforcement (Pharma Letter-$)
  • China FDA Warns Of Serious Adverse Reactions For Cefazolin (PharmAsia-$)

Other International

  • Canada approves infliximab biosimilar (BioCentury)
  • Peruvian regulator amends law for non-commercial device imports (Clinica)
  • Counterfeit drug war in Liberia (IRIN)

General Regulatory And Interesting Articles

  • Scientists create embryonic-type stem cells without embryos (Reuters)
  • Anti-VEGF drugs making a difference in vision, longterm care (Reuters)
  • U.K. researchers unveil an artificial pancreas they've been developing for 20 years (Fierce)

Regulatory Reconnaissance #245 - 29 January 2014

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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