Regulatory Focus™ > News Articles > Regulatory Reconnaissance (13 December 2013)

Regulatory Reconnaissance (13 December 2013)

Posted 13 December 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

In Focus: International

  • EMA publishes report on workshop on regulatory options in the fight against antimicrobial resistance (EMA)
  • Novartis recalls some cough and cold syrup in UK due to defect (Reuters)
  • India: DCGI asks drug cos to provide details about import alert or restrictions on their products by authorities abroad (Pharmabiz)
  • Genzyme's Lemtrada Approved in Canada for Treatment of Multiple Sclerosis (Press)

US: Pharmaceuticals/Biotechnology

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

  • AstraZeneca announces top-line results from phase III monotherapy study of lesinurad in gout patients (Press) (PMLive)
  • Mallinckrodt product meets in Phase III pain trial (BioCentury)
  • AbbVie drug shows promise against difficult type of breast cancer (Reuters)
  • Study: GSK's FluLaval Quadrivalent reduces flu cases among children ages 3 to 8 by 55.4% (DSN)

US: Medical Devices

US: Dietary Supplements

  • More Criminal Cases Likely In Supplement, Food Safety, DoJ Official Says (Tan Sheet-$)

US: Assorted And Government

  • Effect of Budget Deal on FDA (Strengthen FDA)
  • Enforcement Report - Week of December 11, 2013 (FDA)

Upcoming Meetings And Events

  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)
  • 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)

Europe

  • EMA publishes report on workshop on regulatory options in the fight against antimicrobial resistance (EMA)
  • Novartis recalls some cough and cold syrup in UK due to defect (Reuters)
  • Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ (Eisner Safety)

Asia

  • India: DCGI asks drug cos to provide details about import alert or restrictions on their products by authorities abroad (Pharmabiz)
  • India: MHRA and Guj FDCA join hands to strengthen state regulatory mechanism (Pharmabiz)
  • Japan Probes Pharma Magazine Ads Masquerading As Articles (Pharmalot)

Other International

  • N. Zealand Drug-Coverage Agency Rejects Alexion Drug As Too Expensive (PharmAsia-$)
  • Genzyme's Lemtrada Approved in Canada for Treatment of Multiple Sclerosis (Press)

General Regulatory And Interesting Articles

  • All The Things That Cured Cancer In 2013, According To Mail Online (Buzzfeed)
  • When a Medical Test Reveals an Unwelcome Surprise (Scientific American)
  • World's Smallest Pacemaker Can Be Implanted without Surgery (MIT Tech Review) (MDS)
  • Anemia Drug EPO Made by Chemists, Not Cells (MIT Tech Review)
  • What's Fair About Price Discrimination In Pharmaceutical Markets (Forbes)
  • Can The 'Trust Hormone' Make It As A Treatment For Schizophrenia And Autism? (Forbes)
  • Anastrozole reduces breast cancer chance by 53 percent, study says (MedPage Today) (CBS)
  • Does Winter Really Bring On The Blues? Maybe Not (NPR)

Regulatory Reconnaissance #221 - 13 December 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 news@raps.org.


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