Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Weekend Edition (14-15 September 2013)

Regulatory Reconnaissance: Weekend Edition (14-15 September 2013)

Posted 13 September 2013 | By Alexander Gaffney, RAC

Welcome to a special weekend edition of Regulatory Reconnaissance, Focus' regulatory news and intelligence briefing.

In Focus From Focus This Week:

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  • Geriatric Exclusivity For Cancer Drugs Could Drive Needed Research - IoM Report (Pink Sheet)
  • NIH partners with Eli Lilly, others on rare diseases (Fierce) (NIH) (NIH) (NIH) (Fierce) (BioCentury)
  • Meetings: Antiviral Drugs Advisory Committee (FDA)
  • Meetings: Blood Products Advisory Committee (FDA)
Pharmaceuticals and Biotechnology: General
  • J&J trying to drag Boehringer into arbitration over Doxil production lapses (Fierce)
  • US Flu Vaccine Manufacturers: Not Enough Quadrivalent Vax Supply (BioPharma Reporter)
Medical Devices
  • FDA Grants Marketing Authorization to NeoTract's UroLift Implant for Treatment of Prostate-related Urine Flow Problems (FDA) (MedPage Today)
  • Restore Medical's RMS Sterilization Tray System FDA OK'd (MedGadget)
  • RTI Surgical spikes after dodging FDA warning (Mass Device)
Assorted And Government
  • CBO: Reg reform bill would cost $45 million (The Hill)
  • Medicaid Dragging Its Feet Over Generic Drugs (Forbes)
  • Creafuse Powder Grape and Creafuse Powder Fruit Punch: Recall - Contains DMAA (FDA)
Upcoming Meetings And Events
  • 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 18 September 2013: ENVI Meeting, no Known Agenda as of Yet (ENVI)
  • 19 September 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19-20 September 2013: Pediatric Advisory Committee Meeting  (FDA) (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • EMA Paediatric Committee elects new Chair and Vice-Chair (EMA)
  • Germany's BfArM Moves to Electronic-Only eCTD Submission System (BfArM)
  • Guinea-pig firms to test interim UK value-based pricing in 2014 (SCRIP)
  • U.K. groups want drugmakers to guarantee supplies when prices are reduced (Fierce)
  • Keeping 'temporary' drug rebates is 'option' says German HTA (SCRIP)


  • Japan's PMDA To Roll Out New Safety Infrastructure And Drug Development Support (PharmAsia)
  • Johnson & Johnson ex-staffer claims to be whistle-blower in baby powder row (Times of India)

Other International

  • A $500 Million Brawl: Lilly, Canada And Invalidated Patents (Pharmalot)

General Regulatory And Interesting Articles

  • Ketamine, a Darling of the Club Scene, Inspires Development of Next-Generation Antidepressants (Scientific American)
  • Delayed vaccines tied to whooping cough risk (Reuters)

Regulatory Reconnaissance #154 - 14-5 September 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.

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