Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Weekend Edition (12-13 October 2013)

Regulatory Reconnaissance: Weekend Edition (12-13 October 2013)

Posted 11 October 2013 | By Alexander Gaffney, RAC

Welcome to a special weekend edition of Regulatory Reconnaissance, Focus' regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know:

US: Pharmaceuticals/Biotechnology

  • FDA probing serious adverse events linked to Ariad's cancer drug (Reuters) (FDA) (FDA)
  • FDA Approves Sanofi's Nasacort Allergy 24HR for Over-the-Counter Use (Press)
  • Amarin Fish Oil Pill Needs Heart Study Results, FDA Says (Bloomberg)
  • Competitor's data boosts Sarepta's chance of approval for DMD drug (BioFlash)
  • Fresenius Kabi Applauds Missouri Governor for Preventing National Shortage of Anesthesia Drug (Press)

US: Pharmaceuticals and Biotechnology: General

  • Fresenius punished distributor for selling its drug for executions (Fierce)

US: Medical Devices

  • St. Jude Medical CEO knocks regulatory climate, but also offers optimism (Fierce)
  • Gadgets Stuck in FCC Shutdown Pipeline Portend Possible Delay (Bloomberg)

US: Assorted And Government

  • Furloughed FDA Worker Hits The Streets To Drum Up Extra Cash (NPR)
  • 'Routine' FDA inspections of food facilities suspended due to government shutdown (NBC)

Upcoming Meetings And Events

  • 16 October 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 16 October 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 17-18 October 2013: Anti-Infective Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 22-23 October 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA)
  • 24-25 October 2013: Antiviral Drugs Advisory Commitee Meeting (FDA) (Day 2)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • ENVI vote results out: we have a draft legislative resolution (MedDevices Legal)
  • Sanofi Receives CE Mark Approval for JuniorSTAR Half-Unit Insulin Reusable Pen (MedGadget)
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 October 2013 (EMA)


  • All Class I devices now exempt from Korea GMP requirements (Mass Device)
  • Positive EU orphan opinion for Gentium's defibrotide (Pharma Letter-$)

Other International

  • As resistance grows, malaria vaccine raises hopes (IRIN)

General Regulatory And Interesting Articles

  • Researchers Use FAERS to Explore How Drug Combinations Can Be Used to Mitigate Serious Adverse Events (Drug Safety Monitor)

Regulatory Reconnaissance #177 - 12-13 October 2013

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

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