Regulatory Focus™ > News Articles > Regulatory Reconnaissance (17 December 2013)

Regulatory Reconnaissance (17 December 2013)

Posted 17 December 2013 | By Alexander Gaffney, RAC

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.

Your editor will be on break for the Holiday starting 21 December 2013, and returning on 2 January 2014. Regulatory Reconnaissance will not be published during this time.

In Focus: US

  • GSK to stop paying doctors in overhaul of sales practices (Reuters) (NYTimes) (PMLive) (Pharmfile) (Guardian) (FT-$)
  • Congressional Bill Would Restrict Pay-To-Delay Agreements (Pharmalot)
  • Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J (Forbes) (Pink Sheet-$) (BioCentury)
  • Pharma Strikes Out At Supreme Court As Three Recent Cert Petitions Fail (Pink Sheet-$)
  • Should UnBranded Disease Awareness Ads Mention Treatment Risks? (Pharmaguy)
  • HIT Study To Assert FDA Regulates Clinical Software, Guidance Will Follow (IHP-$)
  • Pharmalive, Owner of Industry Giant Ed Silverman's Blog Pharmalot, to Shut Down on 31 December 2013 (Twitter)

In Focus: International

  • EU Clinical Trials Regulation Due to be Published on Friday (AllTrials) (Pharmafile) (SCRIP-$)
  • EMA Sets Budget and Priorities for 2014, Transparency High (PharmExec)
  • Four pharmas breach ABPI Code of Practice (Pharma Times)
  • India: Pharma Industry Group to meet with Regulators to discuss issuance of Written Confirmation Documents After inspection (PharmaBiz)
  • Shanghai Pharma opens bribery probe after whistleblower report (Reuters)

US: Pharmaceuticals/Biotechnology

  • GSK to stop paying doctors in overhaul of sales practices (Reuters) (NYTimes) (PMLive) (Pharmfile) (Guardian) (FT-$)
  • Congressional Bill Would Restrict Pay-To-Delay Agreements (Pharmalot)
  • Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J (Forbes) (Pink Sheet-$) (BioCentury)
  • FDA imposes new hold on PharmAthene SparVax anthrax vaccine program (SCRIP-$) (Press)
  • Pharma Strikes Out At Supreme Court As Three Recent Cert Petitions Fail (Pink Sheet-$)
  • … Which Means Pfizer Now Painted as a RICO Organization (Healthcare Renewal)
  • Gov't Sees Outlier Among Off-Label Cases Under FCA (Law 360-$)
  • 4th Circ. Questions Basis For Generic-Drug Injury Appeal (Law 360-$)
  • Regulation Can Make Drug Ads More Useful (NYTimes)
  • CEO of troubled Amarin heads for the exit as FDA readies Vascepa decision (Fierce) (Pharmalot) (BioCentury)

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

  • Ipsen Announces Positive Initial Results from the International Double-Blind Clinical Phase III Study of Dysport in the Treatment of Adults Suffering from Upper Limb Spasticity (Press)
  • New data on safety and efficacy of Pradaxa in treatment of acute deep vein thrombosis and pulmonary embolism (Press)

US: Medical Devices

  • Booz Allen Hamilton's Priority Recommendations for Device Review Come as No Surprise (FDA Law Blog)
  • HIT Study To Assert FDA Regulates Clinical Software, Guidance Will Follow (IHP-$)
  • ONC's HIT Committee Releases all 2014 Meeting Dates (Federal Register) (FR)
  • FDA Clears Sickle Cell Disease Indication with New Red Blood Cell Exchange (RBCX) Protocol on the Spectra Optia Apheresis System in the United States (Press)
  • FDA clears cloud-connected AgaMatrix iPhone app (MobiHealth News)
  • FDA issues MQSA Report for 2012 (FDA)

US: Assorted And Government

  • U.S. Supreme Court refuses to hear ex-InterMune CEO's appeal (Reuters) (BioCentury) (SCRIP-$)
  • Should UnBranded Disease Awareness Ads Mention Treatment Risks? (Pharmaguy)
  • Groups raise concerns over US-EU trade pact (SCRIP-$)
  • ACUS Report on Regulatory Delays (ACUS)
  • NIH chief to shift more funds to back the most promising drug researchers (Fierce)
  • Coalition Calls on Senators to Reject Tax on Advertising (CHC)
  • Bioethics Commission on incidental findings: Anticipate and communicate (MNT)

Upcoming Meetings And Events

  • 17 December 2013: Risk Communication Advisory Committee Meeting (FDA)
  • 10 January 2013: National Biodefense Science Board Meeting (DHHS)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU Clinical Trials Regulation Due to be Published on Friday (AllTrials) (Pharmafile) (SCRIP-$)
  • EMA Sets Budget and Priorities for 2014, Transparency High (PharmExec)
  • Four pharmas breach ABPI Code of Practice (Pharma Times)
  • Recipharm files for European approval of first-in class generic anti-infective (Pharma Letter-$)
  • Boston Scientific Announces CE Mark Approval And First Implants Of Its Next-Generation X4 Quadripolar CRT-D Systems (Press)
  • Reflection paper on pharmacovigilance communication concerning veterinary medicinal products (EMA)
  • Novartis OTC recall tied to a contractor this time (Fierce)
  • MSD Animal Health Receives Positive Opinion from European Medicines Agency for Bravecto (fluralaner) (Press)

Asia

  • India: Pharma Industry Group to meet with Regulators to discuss issuance of Written Confirmation Documents After inspection (PharmaBiz)
  • Shanghai Pharma opens bribery probe after whistleblower report (Reuters)
  • UAE Legislators Urged To Be Cautious In Regulating Clinical Trials (PharmAsia-$)

Other International

General Regulatory And Interesting Articles

  • Pharmalive, Owner of Industry Giant Ed Silverman's Blog Pharmalot, to Shut Down on 31 December 2013 (Twitter)
  • Case Closed: Multivitamins Should Not Be Used (Forbes) (AP) (NYTimes) (Reuters)
  • Fixing 'Misfolded' Proteins for New Drug Treatments (NPR)
  • How much Genetic Information is too Much? (MIT Tech Review)
  • Scientists hunt for new antibiotics amid a rise in resistant germs (WSJ-$)
  • RandomiseMe: A new website that lets anyone design and run a randomised controlled trial (Bad Science)

Regulatory Reconnaissance #223 - 17 December 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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe