Regulatory Focus™ > News Articles > Regulatory Reconnaissance (15 November 2013)

Regulatory Reconnaissance (15 November 2013)

Posted 15 November 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 provides guidance on development of medicines to prevent stroke in patients with atrial fibrillation (EMA) (EMA)
  • EU approval for Bayer's prostate cancer drug Xofigo (Pharma Letter-$) (Press)
  • No More Mr NICE Guy? Big Pharma Takes On UK Drug Watchdog (PharmExec) (Telegraph)
  • Court Orders German Firm to Pay Victims of Defective Breast Implants (NYTimes)
  • India DCGI To Conduct Routine Inspections Of China API Suppliers (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

US: Pharmaceuticals and Biotechnology: General

  • ONC initiative looks to curb prescription drug abuse (Fierce)
  • PCORI Building Non-Traditional Research Capacity With "Pipeline To Proposal" Awards (Pink Sheet-$)

US: Medical Devices

US: Assorted And Government

  • Enforcement Report - Week of November 13, 2013 (FDA)

Upcoming Meetings And Events

  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA provides guidance on development of medicines to prevent stroke in patients with atrial fibrillation (EMA) (EMA)
  • EU approval for Bayer's prostate cancer drug Xofigo (Pharma Letter-$) (Press)
  • No More Mr NICE Guy? Big Pharma Takes On UK Drug Watchdog (PharmExec) (Telegraph)
  • Carmat aims for EU approval of artificial heart by early 2015 (Reuters)
  • Court Orders German Firm to Pay Victims of Defective Breast Implants (NYTimes)
  • G-BA may assess pre-AMNOG cancer drugs (BioCentury)

Asia

  • India DCGI To Conduct Routine Inspections Of China API Suppliers (PharmAsia-$)
  • China: Anhui Implements Drug Safety Credibility Grading System (PharmAsia-$)

Other International

  • WHO: New malaria vaccines roadmap targets next generation products by 2030 (WHO)

General Regulatory And Interesting Articles

  • Insight: Profit bonanza eludes companies chasing obesity business (Reuters)
  • New IV bag designed for relief workers can turn any water into a sterile saline solution (MedCity News)
  • New device helps patients remember their meds (USA Today)

Regulatory Reconnaissance #203 - 15 November 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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