Regulatory Focus™ > News Articles > Regulatory Recon: GSK to Pay $105M to 40+ States Over Regulatory Lapses (5 June 2014)

Regulatory Recon: GSK to Pay $105M to 40+ States Over Regulatory Lapses (5 June 2014)

Posted 05 June 2014 | By Alexander Gaffney, RAC

Regulatory Recon: GSK to Pay $105M to 40+ States Over Regulatory Lapses (5 June 2014)

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

  • GSK pays $105M to 40-plus US states (FT-$) (AP) (MarketWatch) (Guardian) (Pharma Times) (Law 360-$)
  • Mini-Sentinel and Regulatory Science — Big Data Rendered Fit and Functional (NEJM)
  • Wockhardt recalls 8,712 bottles of hypertension drug in US market (India Times)
  • FDA Product Quality Reviews Could Become Team Effort To Improve Consistency (Pink Sheet-$)
  • Analyst says FDA warning letter to HeartWare is 'as benign as possible' (BioFlash)
  • FDA warns Steris Isomedix on QA, data manipulation issues (Mass Device)
  • FDA Glucose Meter Draft Guidelines Attract More Criticism From Congress (Grey Sheet-$)

In Focus: International

  • Italian Regulators: More Drugs Stolen, Redistributed (EMA) (ANSM)
  • Thalidomide victims launch high court battle for compensation (Guardian)
  • 22 UK hospitals hit by 'infected' drip feed (Independent) (BBC) (MSN)
  • Interview with EU Ombudsman on Trial Data Policy (Pharmalot)
  • APIC offers how-to guidance on distribution of APIs (In-Pharma)

US: Pharmaceuticals/Biotechnology

  • GSK pays $105M to 40-plus US states (FT-$) (AP) (MarketWatch) (Guardian) (Pharma Times) (Law 360-$)
  • Mini-Sentinel and Regulatory Science — Big Data Rendered Fit and Functional (NEJM)
  • Wockhardt recalls 8,712 bottles of hypertension drug in US market (India Times)
  • New campaign pushes for FDA to approve libido drug for women (The Hill)
  • FDA Product Quality Reviews Could Become Team Effort To Improve Consistency (Pink Sheet-$)
  • Relieving the Tension Between FDA’s PLAIR Program and Hatch-Waxman: A New Paper Suggests A Remedy (FDA Law Blog)
  • PhRMA Wary Of Signals That FDA Eying Parallel Review To Lower Drug Prices (IHP-$)
  • Roxane Recalling Calcitriol Solution due to Stability Failure (FDA)
  • FDA proposes reintroducing bovine heparin to prevent shortages (SCRIP-$)
  • Upsher-Smith Receives Final NDA Approval For Vogelxo (Testosterone) Gel CIII (Press)
  • FDA and off-label uses: a balancing act (MM&M)
  • Dermatology, Nasal Sprays Among Emerging OTC Switch Categories (Pink Sheet-$)
  • Glenmark Birth Control Recall Suit Revived In Ohio Court (Law 360-$)
  • New York Wants to Change for Opioids are Prescribed (Scout)

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

  • FDA lifts clinical hold on Halozyme's PEGPH20 (BioCentury) (SCRIP-$)
  • Medicine Co: ORBACTIV (Oritavancin) Phase 3 Trial Results Published in NEJM (Press) (CBS)
  • New York to Hold Clinical Trials for Marijuana-Based Drug Sativex (DD&D) (Pharma Letter-$)
  • Once-Weekly Dalbavancin versus Daily Conventional Therapy for Skin Infection (NEJM)

US: Pharmaceuticals and Biotechnology: General

  • Biotech Consortium Launches KPI Therapeutics, Inc., a New Collaborative Initiative to Speed Drug Development and Improve Investor Outcomes (Press)

US: Medical Devices

  • Analyst says FDA warning letter to HeartWare is 'as benign as possible' (BioFlash)
  • FDA warns Steris Isomedix on QA, data manipulation issues (Mass Device)
  • FDA Glucose Meter Draft Guidelines Attract More Criticism From Congress (Grey Sheet-$)
  • Unique Device Identifiers: 4 tips for compliance (Mass Device)
  • Diabetes: DexCom wins FDA approval for professional glucose monitor (Mass Device)
  • CDRH Looks For Input On Guidance-Development Practices (Grey Sheet-$)
  • Is Regulatory Harmonization Needed for Genomic Data? (NEJM)
  • Tyber Medical Announces 510(K) Clearance for Headless Cannulated Trauma Screw System (Press)
  • QT Vascular Announces FDA Clearance of Chocolate PTCA Balloon Catheter (Press)
  • Kickstarter wants you to crowdfund more things — but still not medical devices (MobiHealthNews)

US: Dietary Supplements

  • Dick's Hard Up: An Adulterated Supplement With Poor SEO (Forbes)
  • Foods and supplements aimed at autism must walk fine regulatory line, attorney says (NI-USA)

US: Assorted And Government

  • FDA chief: Congress cuts funds, expands duties & has unrealistic expectations (SCRIP-$)
  • Congressional Hearing on 21st Century Cures Scheduled (E&C)
  • Enforcement Report - Week of June 4, 2014 (FDA)
  • Mini-Sentinel SOPs (Mini-Sentinel)

Europe

  • Italian Regulators: More Drugs Stolen, Redistributed (EMA) (ANSM)
  • Thalidomide victims launch high court battle for compensation (Guardian)
  • 22 UK hospitals hit by 'infected' drip feed (Independent) (BBC) (MSN)
  • Interview with EU Ombudsman on Trial Data Policy (Pharmalot)
  • EMA accepts Boehringer’s accelerated marketing application for nintedanib in IPF (Pharma Letter-$) (Press)
  • Regulatory talent: The UK industry wants you (SCRIP-$)
  • How to release IMPs in the EU (ECA)
  • Commission establishes expert group on cancer control (EC)
  • European Medicines Agency closed 9 June 2014 (EMA)

India

Japan & China

  • Japan’s First Committee Approves 4 New Drugs (PharmAsia-$)
  • Astellas Files For Approval Cell Culture Influenza Vaccine In Japan (PharmAsia-$)
  • GSK Files For Additional Indication Of Glavamox Dry Syrup For Sinusitis In Japan (PharmAsia-$)
  • Dehaier Receives CFDA Approval for Morpheus Ox Sleep Diagnostic Software (Press)
  • Waters ACQUITY UPLC TQD System Receives Medical Device Approval in China (Press)

Canada

  • Don’t supplement users deserve consumer protection, too? (Science-Based Medicine)
  • Health Canada grants priority review to Hyperion's NDS for Ravicti (PBR)

Other International

  • APIC offers how-to guidance on distribution of APIs (In-Pharma)
  • Expedited COFEPRIS registration planned for South Korean medical devices (Mass Device)
  • The Fight Against Fake Drugs (NYTimes)
  • Where has all the Big Pharma marketing money gone? Emerging markets (Fierce)

General Regulatory And Interesting Articles

  • Boy's Mysterious Infection Cured After DNA Sequencing (NBC) (NYTimes)
  • Viagra may increase melanoma risk, study finds (CBS)

Regulatory Reconnaissance #332 – 5 June 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.

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.

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


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