Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Politicians Pressure FDA on Pain Pill Approval (29 April 2014)

Regulatory Reconnaissance: Politicians Pressure FDA on Pain Pill Approval (29 April 2014)

Posted 29 April 2014 | 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.

In Focus: US

  • FDA Approves Purixan (Mercaptopurine) for ALL (FDA)
  • Dems demand FDA work faster to approve anti-abuse painkiller (The Hill)
  • FDA Willing to "Re-examine" Off-label Policies in Light of First Amendment Rulings (CHC)
  • FDA's Mini-Sentinel System Probing Association Between Gardasil Vaccination and Blood Clots (Mini-Sentinel) (Study Plan)
  • US FDA to revise contact lens guidance in effort to reduce eye infections (Clinica-$) (Gray Sheet-$)

In Focus: International

  • GSK gains EU marketing OK for Incruse for COPD (Pharma Letter-$) (Pharma Times) (BioCentury) (GSK)
  • Backlog on EU standards mounts as Commission takes hard line (Clinica-$)
  • TGA Extends Timeframe for Complying With Joint Reclassification Scheme (TGA)
  • Male researchers stress out rodents (Nature) (Vox)

US: Pharmaceuticals/Biotechnology

  • FDA Approves Purixan (Mercaptopurine) for ALL (FDA)
  • Dems demand FDA work faster to approve anti-abuse painkiller (The Hill)
  • Zogenix Selling Migraine Therapy Business to Focus on Abuse-Resistance of Zohydro (DD&D)
  • FDA Willing to "Re-examine" Off-label Policies in Light of First Amendment Rulings (CHC)
  • FDA's Mini-Sentinel System Probing Association Between Gardasil Vaccination and Blood Clots (Mini-Sentinel) (Study Plan)
  • 2014 Product Security Report: DQSA sets the US industry's agenda for years to come; efforts globally are moving ahead (Pharma Commerce)
  • PhRMA Continues to Push for 12 Year Biologic Exclusivity Provisions in the TPP (PhRMA)
  • How to work with the FDA on biosimilar approvals (SCRIP-$)
  • FDA Plans Pediatric Clinical Investigator Training Workshop (FDA)
  • Extra-strength acetaminophen: For liver's sake, just say no, says FDA (LA Times) (FDA)

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

  • GSK Launches Phase 3 Malaria Drug Trials (DD&D)
  • OncoGenex falls on Phase III CRPC miss (BioCentury) (Fierce)
  • US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • US FDA to revise contact lens guidance in effort to reduce eye infections (Clinica-$) (Gray Sheet-$)
  • FDA chides Indiana pain management doc for unapproved human experiments (Mass Device)
  • 3 Human Factors Failures to Avoid in Medical Device Design (MDDI)
  • Aurora Spine touts FDA wins for spinal fixation devices (Mass Device)
  • NY Bill Would Bar Condoms as Proof of Prostitution (NBC)
  • Siemens' Multix Select DR X-Ray Gets FDA Clearance (MedGadget)

US: Assorted And Government

  • Burwell confirmation hearing set for next week (The Hill)
  • Federal transparency bill headed to White House (The Hill)

Europe

  • GSK gains EU marketing OK for Incruse for COPD (Pharma Letter-$) (Pharma Times) (BioCentury) (GSK)
  • J&J wins EU approval for diabetes combo (PMLive)
  • EC approves Roche's subcutaneous RoActemra (BioCentury)
  • BioMarin's Vimizim gets European approval (BioCentury)
  • Germany's Vaccine Industry In Danger Of Disappearing, Says GSK (Pink Sheet-$)
  • Backlog on EU standards mounts as Commission takes hard line (Clinica-$)
  • European Medicines Agency closed 1 May 2014 (EMA)

Japan & China

  • Bayer Files For Additional Indication Of Adempas For PAH In Japan (PharmAsia-$)

Other International

  • TGA Extends Timeframe for Complying With Joint Reclassification Scheme (TGA)
  • TGA Investigating Power Morcellators After FDA Warning (TGA)
  • Synthes Australia Issues Alert Over its BC Distractor Body (TGA)
  • Opinion: GlaxoSmithKline's Spin Doctoring Doesn't Cure Corruption Problems (Forbes)

General Regulatory And Interesting Articles

  • Male researchers stress out rodents (Nature) (Vox)
  • Higher Doses Of Antidepressants May Raise Teen Suicide Risk (NPR) (Forbes)
  • Stem Cell Therapy To Fix The Heart: A House Of Cards About To Fall? (Forbes)
  • Even a Few Pills Can Put a Dent in the Malaria Rate (NYTimes)
  • Stem cell cloning may be aid treatment for diabetes (CBS)
  • Marijuana Pills Found to Help Reduce Burning Pain of MS (Bloomberg)

Regulatory Reconnaissance #307 - 29 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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A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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