Regulatory Reconnaissance: EU Clinical Trials Overhaul Clears Major Hurdle (23 January 2014)

Posted 23 January 2014 | 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:

In Focus: US

In Focus: International

  • ENVI vote clears way for approval of EU clinical trials law (SCRIP-$) (ENVI-Video) (ENVI)
  • Breakthrough Therapies in U.S. Spur U.K. in Similar Plan (Pharma Times) (Bloomberg) (Fierce)
  • The European Regulatory Outlook for 2014 (PharmExec)
  • CDSCO Launches New Website (CDSCO)

US: Pharmaceuticals/Biotechnology

  • GSK wants collaborative approach to data sharing (PMLive)
  • AMAG slides on FDA rejection of Feraheme label expansion (SCRIP-$) (MedPage Today) (Pharma Times) (BioCentury) (Pink Sheet-$) (The Street)
  • FDA Sponsor Liaison Program Is Not Being Used: Are Small Biotechs Missing An Opportunity? Or Partnering More? (RPM Report-$)
  • Pharma Can Be Liable For Design Negligence: Pa. High Court (Law 360-$)
  • FDA Releases HCT/P Inspection Numbers for 2013 (FDA)
  • Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall - Incorrect Instructions For Use (FDA)
  • Pfizer Escapes Whistleblower Suit Over Lipitor Marketing (Law 360-$)
  • Man-made tracheas move into clinical trial manufacturing phase (Biopharma Reporter)

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

  • Two Alzheimer's drugs fail in clinical trials (Modern Healthcare)
  • BioLineRx Receives Orphan Drug Designation for Novel Stem Cell Mobilization Treatment (Press)
  • Evoke Pharma's inhaled gastro drug better than oral generic (Reuters)
  • Pfizer Reports Top-Line Results From ALO-02 Phase 3 Study (Press)

US: Pharmaceuticals and Biotechnology: General

  • Lilly backs track-and-trace and commits $102m to fight counterfeits (In-Pharma)
  • NIH backs New York MERS-CoV vaccine development program (Fierce)

US: Medical Devices

  • FDA's Approvals of Cardiac Implantable Electronic Devices Have Used Varying Levels of Evidence: Research (JAMA) (Fierce) (Medpage Today)
  • Medtronic lands FDA win for full-body MRI with SureScan pacemakers (Mass Device) (MedGadget)
  • Quality System Regulations - What You Need to Know (MedicalDeviceSummit)
  • Meeting for Software Developers on the Common Formats for Patient Safety Data Collection and Event Reporting (AHRQ)
  • Supreme Court tosses out Medtronic pacemaker patent loss (Reuters) (SCRIP-$) (Law 360-$) (Mass Device) (Gray Sheet-$) (Fierce)
  • Appeals court upholds Edwards Lifesciences win over Medtronic in heart valve spat (Mass Device)

US: Dietary Supplements

  • What's in Your Fish Oil Supplements? (NYTimes)

US: Assorted And Government

  • IOM Asks for Input on How to Best Share Clinical Data (NEJM) (Modern Healthcare)
  • FDA's collaboration with Europol bears first fruit (Securing Industry)
  • Transforming Professional Medical Education -- Role of the FDA (Policy and Medicine)
  • PhRMA: US STEM gap imperils nation's competitiveness, innovative leadership (SCRIP-$)

Upcoming Meetings And Events

  • 28 January 2014: Allergenic Products Advisory Committee Meeting (FDA)
  • 28 January 2013: US State of the Union Address (White House)
  • 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)


  • ENVI vote clears way for approval of EU clinical trials law (SCRIP-$) (ENVI-Video) (ENVI)
  • Breakthrough Therapies in U.S. Spur U.K. in Similar Plan (Pharma Times) (Bloomberg) (Fierce)
  • The European Regulatory Outlook for 2014 (PharmExec)
  • BfArM, Swissmedic opt for more cross-border regulatory networking (SCRIP-$)
  • EDQM announces the extension of its ISO 9001:2008 Certification to the conduct of laboratory studies (EDQM)
  • The EDQM adds Nuclear magnetic resonance (NMR) to its analytical competencies (EDQM)
  • Eisai's amatuximab get orphan status in Europe (Pharma Times) (Press)
  • BMJ editorial suggests a routine audit of clinical trials (AllTrials)
  • Masimo Announces CE Marking of O3 Regional Oximetry (Press)


  • CDSCO Launches New Website (CDSCO)

Japan & China

  • Nu Skin Under Investigation In China For Pyramid-Scheme Allegations (Tan Sheet-$) (Law 360-$)

General Regulatory And Interesting Articles

  • The Flu Vaccine Is Safer Than We Knew (Slate)
  • The toll of the anti-vaccination movement, in one devastating graphic (LATimes)
  • Syria's Polio Epidemic: The Suppressed Truth (NYBooks)
  • EndoType: Cautions on Registry Data (MedPage Today)
  • Weight loss pill turns into balloon when swallowed (CBS)

Regulatory Reconnaissance #241 - 23 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.

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