Regulatory Focus™ > News Articles > Regulatory Reconnaissance (25 July 2013)

Regulatory Reconnaissance (25 July 2013)

Posted 25 July 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • GlaxoSmithKline agrees to pay $229 million to settle state-related Avandia claims in US  (First World Pharma) (Reuters) (Law 360)
  • Two-Day Meeting on REMS Gets Underway Today (FDA) (Focus)
  • U.S. drugmakers cheer 'speed lane' for breakthrough therapies (Reuters)
  • Exclusivity Could Be Carrot to Coax Supplement NDI Compliance, But is it Legal? (Pink Sheet)
  • FDA's Stockbridge wants agency to move from QT trials (BioCentury)
  • Bribes, Sex, Fraud! Did Glaxo Violate Its Corporate Integrity Agreement? (Pharmalot)
  • Sarepta's Latest Bid In Race For DMD Indication: Submit NDA With Phase IIB Data (Pink Sheet) (PharmPro) (BioCentury) (SCRIP)
  • Clinical Trial Results for Cancer Drugs Often Not Published (Physicians Briefing)
  • Be Sure To Include Method Claims In A Pharma Product App (Law 360)
  • LeMaitre graft recall gets FDA's highest warning (Mass Device) (FDA)

In Focus: International

  • Study: Use Of Comparative Effectiveness Research By Four European Health Authorities (Healthcare Economist)
  • Four Legislation Developments in the EU that Don't Have to do with the Device/IVD Legislation (MedicalDevicesLegal)
  • Pharma industry downplays lobbyism with patient groups (EurActiv)
  • Pharmaceutical Companies Accused of Participating in Private Investigation Scandal (Independent)
  • Beijing takes on big beasts of global drugs industry (FT)
  • China detains couple who run risk consultancy (FT)
  • Generic Drug Bioequivalence Testing Details Emerge In China (Gold Sheet)
  • GSK's China Misadventures Put Heat On Foreign Drug Trials (Law 360)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • GlaxoSmithKline agrees to pay $229 million to settle state-related Avandia claims in US  (First World Pharma) (Reuters) (Law 360)
  • U.S. drugmakers cheer 'speed lane' for breakthrough therapies (Reuters)
  • FDA's Stockbridge wants agency to move from QT trials (BioCentury)
  • Bribes, Sex, Fraud! Did Glaxo Violate Its Corporate Integrity Agreement? (Pharmalot)
  • Sarepta's Latest Bid In Race For DMD Indication: Submit NDA With Phase IIB Data (Pink Sheet) (PharmPro) (BioCentury) (SCRIP)
  • "Major" Drug Labeling Changes That Require FDA Prior Approval (Drug and Device Law)
  • Breo Launch Timing Slips But No "Drama," GSK's Witty Says (Pink Sheet)
  • Clinical Trial Results for Cancer Drugs Often Not Published (Physicians Briefing)
  • Source: HELP Committee has New Consensus Drug Compounding Bill (Twitter)
  • Lack of Microbiological Controls Had Grave Consequences for Compounders (Gold Sheet)
  • A Lesson on Outsourcing: The NECC Fungal Meningitis Outbreak (Gold Sheet)
  • Early Notification Helping to Resolve Drug Shortages (Gold Sheet)
  • PreScience Labs Announced that the FDA Accepts IND Application for Novel Oncology Drug (PreScience Labs)
  • Filings In The Second Half Could Be Transformative For The Medicines Co. (Pink Sheet)
  • Novel Pulmonary Hypertension Drug From Bayer Shows Modest Promise In Phase 3 Trials (Forbes)
  • Orion, Mylan settle patent dispute over Parkinson's drug Stalevo (Reuters)
Pharmaceuticals: General
  • Pharmaceutical Companies Starting to Adopt Track-and-Trace Systems (Gold Sheet)
  • Big Pharma Shrinks Peddling of Big Influence (Open Secrets)
  • PhRMA comes out on top in trade group rankings (The Hill)
Medical Devices
  • Be Sure To Include Method Claims In A Pharma Product App (Law 360)
  • LeMaitre graft recall gets FDA's highest warning (Mass Device) (FDA)
  • Can hackers and medical device makers play nice? (Mass Device)
  • Boston Scientific Receives FDA 510(k) Clearance for the Rhythmia Mapping System (Boston Scientific) (BioFlash)
  • Terason uSmart 3200T Receives CE Mark and 510(k) FDA Clearance (Terason)
  • GE Initiates Huge Class 1 Recall After Patient Dies from Nuclear Medicine System (FDA) (FDA) (FDA) (FDA) (FDA) (FDA) (FDA)
  • Vendors, Physicians Call For Delay In E-Health Record Meaningful Use Regs To Get Interoperability Right (Pink Sheet)
Assorted And Government
  • Exclusivity Could Be Carrot To Coax Supplement NDI Compliance, But is it Legal? (Pink Sheet)
  • House panel advances bills to rein in regulations (The Hill) (US PIRG) (CBO)
  • Avoiding an FCPA or anti-bribery charge after uncovering corruption (Inside Counsel)
  • FDA's Special Agents: On the Job to Protect the Public (FDA)
  • Enforcement Report - Week of July 24, 2013 (FDA)
  • Lawmakers fear doubling of regulations from US-EU trade deal (The Hill)
  • White House claims billions in savings from eased regulations (The Hill)
  • Anti-Patent-Trolling Bill Introduced in House (Congress)
  • Senators introduce bill to limit lavish government conferences (Enzi)
Upcoming Meetings And Events
  • 22-23 July 2013: Arthritis Advisory Committee Meeting (FDA)
  • 23 July 2013: Meeting: Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study (FDA)
  • 23 July 2013: Hearing: "Pay-for-Delay Deals: Limiting Competition and Costing Consumers" (Senate Judiciary Cmmte)
  • 23 July 2013: Brookings Webinar: Active Medical Product Surveillance Roundtable (FDA)
  • 24 July 2013: Answering a Compelling Need: Expediting Life-Saving Treatments to Patients (FOCR)
  • 24 July 2013: House Hearing on US-EU Free Trade Agreements and Regulatory Barriers (House)
  • 25 July 2013: CBER Webinar on its Direct Recall Classification Program (FDA)
  • 25 July 2013: Webinar on FDA's Draft GFI on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment (FDA)
  • 25 July 2013: Webinar on FDA's Draft GFI On Rheumatoid Arthritis - Developing Drug Products For Treatment (FDA)
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Study: Use Of Comparative Effectiveness Research By Four European Health Authorities (Healthcare Economist)
  • Four Legislation Developments in the EU that Don't Have to do with the Device/IVD Legislation (MedicalDevicesLegal)
  • Pharma industry downplays lobbyism with patient groups (EurActiv)
  • Pharmaceutical Companies Accused of Participating in Private Investigation Scandal (Independent)
  • Epsilon Imaging Receives CE Mark for the EchoInsight® Visualization and Analysis Platform with Practical Strain Imaging for Improved Echo Interpretation (Epsilon)
  • In the EU, to QbD or not to QbD? That is the Question... (BioPharma Reporter)
  • German rebate exemptions under threat (SCRIP)

Asia

  • Beijing takes on big beasts of global drugs industry (FT)
  • China detains couple who run risk consultancy (FT)
  • Generic Drug Bioequivalence Testing Details Emerge In China (Gold Sheet)
  • GSK's China Misadventures Put Heat On Foreign Drug Trials (Law 360)
  • Faced With 2 Accusers, Glaxo's Responses Differ (WSJ)
  • India Not Target Of U.S. FDA Witch-Hunt, Analysts Say (PharmAsia)
  • China's State-Run News Agency Hints More Drug-Maker, Hospital Probes (PharmAsia)
  • Ropes & Gray To Investigate GSK Bribery Scandal In China (Law 360)

General Regulatory And Interesting Articles

  • Mercury And Autism Not Linked, Again (Forbes)
  • Advancing antimalarial drug research through open source initiatives (Guardian)

Regulatory Reconnaissance #116  - 25 July 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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