Regulatory Reconnaissance: What's Next for Medical Device Regulation in the EU? (7 April 2014)

Posted 07 April 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

  • After Vote, What's Next for the MDR and IVDR Legislation? (MDL)
  • Confidentiality Definition Comes Closer After AbbVie Drops EMA Cases (Pink Sheet-$)
  • India's drug inspectors hard-pressed to scrutinize factories (Reuters)
  • Drugmaker GSK investigates alleged bribery in Iraq (Reuters) (NYTimes) (Bloomberg)
  • Amgen calls on pharma to educate doctors on biosimilars (BioPharma Reporter)

US: Pharmaceuticals/Biotechnology

  • FDA head says agency's work has helped shorten time needed for drug approval (BioFlash) (BetaBoston) (Boston Herald)
  • MannKind says FDA delays decision on inhaled insulin treatment (Reuters)
  • FDA Approves Pradaxa (dabigatran etexilate mesylate) for Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism (Press)
  • Congressional Hearing on "Improving Predictability and Transparency in DEA and FDA Regulation" Today (FDA Law Blog)
  • Clinical Trial Subgroup Data: How Much Is Enough? (Pink Sheet-$) (Pink Sheet-$)
  • States try to block new powerful painkiller Zohydro (CBS) (SCRIP-$)
  • FDA's OK of opioid overdose treatment doesn't quell backlash over Zohydro (Fierce)
  • FDA Suppresses Concerns About Indian Generics (Real Clear Policy)
  • FDA Urged To Change OTC Monograph System, But Not In Midstream (Tan Sheet-$)
  • Afrezza Review Shows Need For Patient-Driven Endpoints In Diabetes (Pink Sheet-$) (Pink Sheet-$)
  • Stick To Basics: Attempt To Improve Heart Failure Symptomatic Endpoint Trips Up Novartis' Serelaxin (Pink Sheet-$)
  • Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? (RxTrace)
  • Alzheimers: FDA approval of dementia drug based on biomarkers? (MedPage Today)
  • Merck wants to test Zilmax on 240,000 cattle but beef industry resists (Reuters)
  • Dyax drug for rare swelling disease approved for use in younger patients (BioFlash)
  • GPhA Op-Ed in the NYTimes on FDA's Generic Drug Labeling Rule (NYTimes)

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

  • Guarded Optimism After Pfizer's Breast Cancer Drug Palbociclib Shows Promising Results (NYTimes) (Reuters) (Bloomberg) (WSJ-$) (Forbes) (Pharmafile) (PMLive) (Pharma Times) (Fierce) (Bloomberg)
  • Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C (Press)
  • Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection (Press)
  • Genzyme to Resubmit Lemtrada Application for FDA Review (Press) (Fierce) (Pharma Letter-$)
  • Two deaths force MSK to hit the brakes on engineered T cell cancer study (Fierce)
  • Amgen melanoma drug fails to improve overall survival rates (Reuters) (SCRIP-$) (Press) (Fierce) (Fierce)
  • Novartis' meningitis B vaccine wins breakthrough therapy status in U.S. (Reuters)
  • Santen Phase III Study Meets Primary Endpoint for the Treatment of Non-Infectious Posterior Segment Uveitis (NI-PSU) (Press)
  • Ph III data shows Pacira' Exparel good as femoral nerve block in knee arthroplasty (Pharma Letter-$)

US: Pharmaceuticals and Biotechnology: General

  • New Mandate for Coverage of Obesity Drugs (MedPage Today)
  • Glance: Execution drug secrecy in 5 states (AP)
  • Should Med School Leaders Serve On Pharma Boards? (Forbes)

US: Medical Devices

  • Not much new in FDASIA report, Congress still champing at the bit (MobiHealthNews) (mHealthNews)
  • J&J Hit With $1.2M Verdict In Texas Pelvic Mesh Trial (Law 360-$) (Mass Device) (Fierce)
  • Recent FDA Software Recall Re-Ignites Debate Around HIT Legislation (IHP-$)
  • Consumer's Union, Public Citizen, Others Campaign for Wider Adoption of UDI Standards (Letter)
  • Calgary Scientific Receives FDA Clearance for Mobile Diagnosis on all Modalities (Press)
  • Via Surgical Ltd. Receives FDA Clearance for FasTouch, the First Suture-Like Mesh Fixation System for Hernia Repair (Press)

US: Assorted And Government

  • Even Small Medical Advances Can Mean Big Jumps in Bills (NYTimes)
  • Where Does $225 Million Come From for FDA in FY 15? (Strengthen FDA) (2)
  • BIO Calls for Adequate Funding of Vaccine and Biodefense Programs (BIO)


  • After Vote, What's Next for the MDR and IVDR Legislation? (MDL)
  • Confidentiality Definition Comes Closer After AbbVie Drops EMA Cases (Pink Sheet-$)
  • Edwards Lifesciences lands E.U. approval for INTUITY Elite aortic valve (Mass Device) (MedGadget)
  • NICE issues draft OK for Genzyme's Lemtrada in RRMS (Pharma Times)
  • Nexcyon Achieves European Regulatory Decision for Veterinary Drug (Press)


Other International

General Regulatory And Interesting Articles

  • Eli Lilly hatches its most expensive, complex plan against counterfeit drugs yet (MedCity News)
  • Amgen calls on pharma to educate doctors on biosimilars (BioPharma Reporter)
  • Anti-vaccine movement is giving diseases a 2nd life (USA Today)

Regulatory Reconnaissance #292 - 7 April 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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