Regulatory Focus™ > News Articles > Regulatory Recon: Medical Device Companies Under Bribery Suspicion in China (4 May 2015)

Regulatory Recon: Medical Device Companies Under Bribery Suspicion in China (4 May 2015)

Posted 04 May 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Medical Device Companies Under Bribery Suspicion in China (4 May 2015)

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

In Focus: US

  • Head of FDA's device arm says agency aims to be first in the world to improve devices (Fierce)
  • Long-Term Data on Complications Adds to Criticism of Contraceptive Implant Essure (NYTimes) (MassDevice)
  •  ‘Breakthrough’ Request Success Tied To Data Reliability (Pink Sheet-$)
  • Unsure About ‘Breakthrough’-Worthiness? Talk To FDA First (Pink Sheet-$)
  • Evaluating the changing landscape of health care antiseptics (FDA)
  • Gilead’s Gaffe Leads Drugmakers to Pledge More Openness on Price (Bloomberg)
  • Sens. Ask FTC To Probe Supplements With Untested Ingredient (Law 360-$) (The Hill) (NPI)
  • FDA Staying The Course Under Ostroff; Hamburg’s Concerns Remain Focus (Tan Sheet-$) (RPM Report-$)

In Focus: International

  • China Said to Probe Medical Device Firms on Bribery Suspicions (Bloomberg) (Reuters)
  • Medical device reports by EU competent authorities on the wane? (Clinica-$)
  • India, Europe talks on IP tussles break down (Fierce)
  • Mylan launches hepatitis-C Sovaldi tablets in India (IndiaTimes) (Fierce)
  • China Said to Probe Medical Device Firms on Bribery Suspicions (Bloomberg) (Reuters)
  • Biosimilar substitution on the table in Australia (SCRIP-$)

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US: Pharmaceuticals and Biotechnology

  • ‘Breakthrough’ Request Success Tied To Data Reliability (Pink Sheet-$)
  • Unsure About ‘Breakthrough’-Worthiness? Talk To FDA First (Pink Sheet-$)
  • Totality Of ‘Breakthrough’ Evidence Guides FDA Designation Decisions (Pink Sheet-$)
  • ‘Breakthrough’ Fee Eyed As Deterrent To Frivolous Requests (Pink Sheet-$)
  • Ala. Undoes Brand Drug Liability For Generic Injury (Law 360-$)
  • From our perspective: Evaluating the changing landscape of health care antiseptics (FDA)
  • The DSCSA Product Identifier On Drug Packages (RxTrace)
  • The Language Of The DQSA Contradicts Congressional Intent (Law 360-$)
  • Woodcock: Measurement Key to Quality (IPQ-$)
  • Right-to-Try Bill Advances in Minnesota (MPR News)
  • PRO-ving Ground: FDA Review Teams Commit to Patient-Reported Outcomes (RPM Report-$)
  • U.S. clinics avoiding government oversight of "stem cell" treatments (MNT)
  • Abuse-Deterrent Zohydro Launched (Press)
  • Identification of drug-specific pathways based on gene expression data: application to drug induced lung injury (PubMed)
  • FDA grants tentative approval for Amerigen's generic Toviaz (PBR)

US: Pharmaceuticals and Biotechnology: General

  • Gilead’s Gaffe Leads Drugmakers to Pledge More Openness on Price (Bloomberg)
  • Generic Vicodin Was a Top Medicare Drug in 2013, Data Shows (WSJ-$) (Data)
  • House Draft Bill Drops CME Payment Disclosures to Sunshine Database (Pharmalot)
  • Why Medicare's List Of Costly Drugs Is Kind Of Bogus (Forbes)
  • Oversight Committee Continues Hearing Series to Review Prescription Drug & Opioid Abuse (E&C)
  • Bass challenges second Tecfidera patent (BioCentury) (NationalJournal)
  • Express Scripts to Pay $60M to Settle Novartis Kickback Scheme (Pharmalot)

US: Medical Devices

  • Long-Term Data on Complications Adds to Criticism of Contraceptive Implant Essure (NYTimes) (MassDevice)
  • Head of FDA's device arm says agency aims to be first in the world to improve devices (Fierce)
  • The New Frontier of 3D Printing and Medical Device Approvals (PCM)
  • Cartiva, Inc. Announces Submission of Final Module of PMA Application for Cartiva SCI (Press)
  • FDA Clears Invictus Medical’s GELShield for Market Launch (Press)
  • Medtronic Neurosurgery Receives Expanded Indications for the StealthStation Electromagnetic Surgical Navigation Technology (Press)
  • Could The Innovation Act Stifle Medical Device Innovation? (MDO)

US: Dietary Supplements

  • Sens. Ask FTC To Probe Supplements With Untested Ingredient (Law 360-$) (The Hill) (NPI)
  • The Costs of the GNC Agreement with the New York Attorney General (NPI)
  • Industry has face-to-face meetings with NY attorney general’s office (NewHope360)

US: Assorted And Government

  • FDA Staying The Course Under Ostroff; Hamburg’s Concerns Remain Focus (Tan Sheet-$) (RPM Report-$)
  • The Case Against the 21st Century Cures Act (ModernHealthcare)
  • FDA Officials Welcome House Plan To Remove Agency Hiring Barriers (Gray Sheet-$)
  • Alexander Tells FDA To Create ‘Red Team’ For Regulatory Streamlining (Tan Sheet-$)
  • FDA Hoping To Shift Some ‘Cures’ Initiatives Toward User Fee Negotiations (Tan Sheet-$)
  • This week’s regulatory and legislative news from PwC (PwC HRI)

Upcoming Meetings and Events

Ebola Outbreak

  • Ebola can spread through sex much longer than experts thought (AP) (Reuters)

Europe

  • Medical device reports by EU competent authorities on the wane? (Clinica-$)
  • India, Europe talks on IP tussles break down (Fierce)
  • Sobi says EMA committee positive to new Orfadin formulation (Reuters)
  • EspeRare's Investigational Compound Rimeporide Receives European Orphan Drug Designation in Duchenne Muscular Dystrophy (Press)
  • AIT's Cystic Fibrosis Treatment Granted European Orphan Drug Designation (Press)

India

  • Mylan launches hepatitis-C Sovaldi tablets in India (IndiaTimes) (Fierce)
  • Final Warning From NPPA To 59 Pharma Companies To Register On IPDMS (24 Insight)
  • KDPMA alerts DCGI on circulation of unapproved FDCs across central-state govt hospital supply chain (PharmaBiz)

China

  • China Said to Probe Medical Device Firms on Bribery Suspicions (Bloomberg) (Reuters)
  • Bayer's Xarelto Approved in China (Press)
  • Viagra Keeps Pfizer’s China Sales Rising (Bloomberg)

Australia

  • Biosimilar substitution on the table in Australia (SCRIP-$)
  • Pharmacy Guild threatens campaign over $1 discount that could save $400m (Guardian)
  • Power Wheelchairs Recalled in Australia Due to Fire Risk (TGA)

Other International

Clinical Trials

  • Changes in clinical trial length: Trials Getting Shorter on Average (Nature) (InThePipeLine)
  • Progress and Barriers on Clinical Trials Transparency (YouTube)
  • Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis (PubMed)

General Regulatory And Interesting Articles

  • Why Your Future Vaccination Might Not Be A Shot (NPR)
  • Biotech Workers Win $58 Million Lottery Drawing, to Split Prize (DD&D)

Regulatory Reconnaissance #549 – 4 May 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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