Regulatory Focus™ > News Articles > Regulatory Recon: FDA Hits Medtronic With Consent Decree (28 April 2015)

Regulatory Recon: FDA Hits Medtronic With Consent Decree (28 April 2015)

Posted 28 April 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Hits Medtronic With Consent Decree (28 April 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

In Focus: International

  • China FDA wants to end use of intermediaries in drug approval process (Fierce)
  • Sakigake: New Japanese drug laws will foster global innovation says MHLW (BioPharma-Reporter)
  • How the Ebola outbreak sparked the fastest vaccine development efforts ever (BioCentury-$)
  • EU stands firm on biosimilar naming as WHO pursues qualifier plan (SCRIP-$)
  • EU special committee battles with single-use device and other tricky issues (Clinica-$)
  • Early access initiatives – one year on (PharmaPhorum)
  • ‘Africa needs more efficient regulatory systems to improve access to medicines’ (PharmAfrica)

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US: Pharmaceuticals and Biotechnology

  • India's Wockhardt to recall some drugs made in India after U.S. FDA concerns (Reuters) (BusinessLine)
  • Amarin Sent a Complete Response Letter Over Vascepa sNDA (Press)
  • FDA reviewers take issue with Amgen's T-Vec trial (BioCentury) (Pink Sheet-$) (Tarius) (SCRIP-$)
  • Takeda Agrees to Pay $2.3 Billion to Settle Actos Cases (Bloomberg)
  • China hopes to learn ins and outs of regulation from U.S. FDA (Fierce)
  • FDA Releases PDUFA Financial Report (FDA)
  • Opinion: The FDA's 'orphan drug' efforts are warping the incentives for pharmaceutical research. (USNews)
  • PhRMA Authors Call for FDA to Establish Off-label Communication Safe Harbor (CHC)
  • Critical Path Institute Secures Regulatory Support for Parkinson’s and Alzheimer’s Disease Biomarkers (Press)
  • Opinion: Congress Should Hold Oversight Hearings to Ensure FDA Prioritizes Safety for Biosimilars (RollCall)

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

US: Pharmaceuticals and Biotechnology: General

  • Biogen to Spend $2.5 Billion Before Alzheimer’s Drug Results (Bloomberg)
  • Obama Proposes That Medicare Be Given the Right to Negotiate the Cost of Drugs (NYTimes)
  • Tyson Foods plans to cut human antibiotics in U.S. chicken flocks by 2017 (Reuters)

US: Medical Devices

  • FDA: Medtronic Must Stop Most Sales of Synchromed Drug Pumps (AP) (FDA) (Policy and Medicine) (WSJ-$) (MedTronic) (Mass Device) (Law 360-$) (Fierce) (GraySheet-$) (Reuters) (DOJ)
  • Two U.S. hospitals to test startup's novel medical device malware detection software (Fierce)
  • CryoLife Announces Resolution of FDA Warning Letter (Press)
  • February 2015 PMA Approvals (FDA)
  • New Data Evaluating The Boston Scientific Eluvia Drug-Eluting Vascular Stent System Demonstrate 94.4 Percent Primary Patency Rate At Nine Months (Press)
  • FDA clears blood-glucose testing device from Nipro Diagnostics (DSN)
  • FH Ortho Receives FDA 510(K) Clearance for Its Arrow Reverse Shoulder Long Keel & Short Keel Glenoid Base (Press)

US: Assorted And Government

  • FDA BIMO Inspections Increase 11 Percent in FY 2014 (Thompson's) (FDA)
  • HRI regulatory center weekly newsletter: This week’s regulatory and legislative news (PwC)

Upcoming Meetings and Events

Ebola Outbreak

  • How the Ebola outbreak sparked the fastest vaccine development efforts ever (BioCentury-$)
  • What lessons from Ebola can prepare society for other outbreaks (BioCentury-$)

Europe

  • EU stands firm on biosimilar naming as WHO pursues qualifier plan (SCRIP-$)
  • EU special committee battles with single-use device and other tricky issues (Clinica-$)
  • Early access initiatives – one year on (PharmaPhorum)
  • Workshop This Week on Medical Countermeasures and Seasonal Influenza (EC)
  • Avastin authorized for UK advanced cervical cancer patients (PharmaLetter-$)
  • GSK readies 'bubble boy' drug as big pharma bets on gene therapy (Reuters)
  • Is a UK market access shake-up on the cards? (PMLive)
  • Public consultation on the Position paper on how to best formulate research recommendations for primary research arising from HTA reports. (EUnetHTA)
  • PBT2 Recommended for Orphan Designation in Europe (Press)

Japan

  • Sakigake: New Japanese drug laws will foster global innovation says MHLW (BioPharma-Reporter)
  • Japan MHLW panel names 11 unapproved/off-label drugs for fast-track reviews (Fierce)

China

  • China FDA wants to end use of intermediaries in drug approval process (Fierce)

Canada

  • Ortho-Clinical Diagnostics, Inc. Receives Health Canada Approval for ORTHO VISION Analyzer (Press)

Australia

  • TGA Launches New Business Services Website (TGA)

Other International

  • ‘Africa needs more efficient regulatory systems to improve access to medicines’ (PharmAfrica)

General Regulatory And Interesting Articles

  • Enough to Make You go Mab: The Increasingly Confusing Names of Biologics (BMJ)
  • Microneedle Patch for Measles Vaccination Could Be a Game Changer (CDC)
  • Mitochondrial gene editing could add to debate (BioCentury)

Regulatory Reconnaissance #545 – 28 April 2015

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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