Regulatory Focus™ > News Articles > Regulatory Reconnaissance (26 November 2013)

Regulatory Reconnaissance (26 November 2013)

Posted 26 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

  • Upcoming ENVI Meeting to Set Pharmacovigilance Fees for EMA (ENVI)
  • Hepatitis C: Boehringer Ingelheim's faldaprevir granted accelerated assessment from EMA (Press)
  • EMA-HTA workshop on parallel scientific advice in drug development takes place today (EMA) (EMA)
  • USP Looks To Maximize Opportunity As China Builds Drug Standards (PharmAsia-$)
  • India: ISCR raises concern over hasty introduction of audio-visual recording of informed consent (Press)

US: Pharmaceuticals/Biotechnology

US: Pharmaceuticals and Biotechnology: General

  • Michigan, Massachusetts team up on meningitis outbreak case (Boston Herald)

US: Medical Devices

  • BSX scores FDA device approval for drug-eluting stent for coronary artery disease patients (MedCity News) (Mass Device) (Cardiovascular Business)
  • Frustration From a Deal on Flawed Hip Implants (NYTimes)
  • CLR Medicals International Inc. Issues Nationwide Recall of Viscoelastic Products (FDA)
  • Bard Submits Final PMA Module to the FDA for the Lutonix Drug-Coated Balloon (Press) (Mass Device)
  • Hospira GemStar Infusion System: Class I Recall (FDA) (FDA)
  • Medtronic touts 3-year data for Endurant II AAA stent graft (Mass Device)
  • Bruker Corporation Announces FDA Clearance to Market the MALDI Biotyper CA System (Press)
  • eZono Receives CE Mark for eZono 4000 Tablet Ultrasound System with eZGuide (Press)

US: Dietary Supplements

  • NDI Submissions Fare Better With Early FDA Contact (Tan Sheet-$)
  • Having the right quality control talent on staff is key, AHP chief says (Nutra Ingredients)

US: Assorted And Government

Upcoming Meetings And Events

  • 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

  • Upcoming ENVI Meeting to Set Pharmacovigilance Fees for EMA (ENVI)
  • Hepatitis C: Boehringer Ingelheim's faldaprevir granted accelerated assessment from EMA (Press)
  • EMA-HTA workshop on parallel scientific advice in drug development takes place today (EMA) (EMA)
  • Key piece of Roche, Novo Nordisk diabetes device deal nears EU approval (Fierce)
  • BonAlive Biomaterials Gets CE Mark for BonAlive Putty (MedGadget)
  • More woe for OxyElite Pro as Euro ban widens (Nutra Ingredients)
  • UK report criticizes Border Force's failure to seize fakes (Securing Industry)
  • Calls for parliamentary inquiry into 'specials' price rigging (Pharma Times)

Asia

  • USP Looks To Maximize Opportunity As China Builds Drug Standards (PharmAsia-$)
  • India: ISCR raises concern over hasty introduction of audio-visual recording of informed consent (Press)
  • Advocates Try To Block Gilead Patent For Hep C Drug In India (Pharmalot) (Pharma Times)

General Regulatory And Interesting Articles

  • Clinical Trial Sponsors Struggle with Data Disclosure Requirements (PharmExec)
  • Over-the-counter sleep aids: The research on their effectiveness is limited, experts say (Washington Post)
  • Pfizer: Active role for patients as smartphones lead way in virtual trials (Outsourcing Pharma)
  • Drug interactions causing a significant impact on statin use (EurekAlert)

Regulatory Reconnaissance #210 - 26 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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