Regulatory Focus™ > News Articles > Regulatory Reconnaissance (11 October 2013)

Regulatory Reconnaissance (11 October 2013)

Posted 11 October 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.

In Focus: US

  • Relief for Ranbaxy as US GMP woes appear to ease (SCRIP-$) (Fierce)
  • Drugmakers try to outflank White House on Biosimilars in trade agreement (The Hill)
  • Compounding Concerns Unlikely To Sideline Bill's Progress, Sources Say (IHP-$)
  • GPhA Tactics In Fight Against Calif. Biosimilar Bill Draw FDA Attention (Pink Sheet-$)
  • FDA approves new pediatric use for Liposorber Apheresis System (FDA)
  • A Solution to Regulatory Delay: End Centralized White House Regulatory Review (Huffington Post)

In Focus: International

  • ENVI Posts Text of Medical Device Directive Overhaul (ENVI)
  • India to invest $3B to overhaul drug manufacturing inspections (In-Pharma) (Pharmalot)
  • Health Canada switching to electronic delivery of medical device licenses (Mass Device)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 October 2013 (EMA)
  • EMA to Host Upcoming Workshop on Biosimilars (EMA)

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

US: Pharmaceuticals/Biotechnology

  • Relief for Ranbaxy as US GMP woes appear to ease (SCRIP-$) (Fierce)
  • Drugmakers try to outflank White House on Biosimilars in trade agreement (The Hill)
  • Compounding Concerns Unlikely To Sideline Bill's Progress, Sources Say (IHP-$)
  • FDA Files Genentech's Supplemental Biologics License Application of Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU) (Press)
  • GPhA Tactics In Fight Against Calif. Biosimilar Bill Draw FDA Attention (Pink Sheet-$)
  • Culture Clash: U.S. FDA Tries to Re-educate Indian Firms on Processes And Accurate Reporting (PharmAsia-$)
  • Acceptability Of Revised Study Expected To Be On Agenda For Northera Advisory Panel (Pink Sheet-$)
  • New Phase III patiromer data boost Relypsa's IPO prospects ahead of planned filing (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • German firm blocked shipments to U.S. distributor after drug sent for executions (Reuters)
  • Rx Drug Donation System Hopes To Grow (CA Healthline)
  • CMS Needs Payment Reform Ideas For Rare Diseases From Private Sector - Former Official (Pink Sheet-$)

US: Medical Devices

  • FDA approves new pediatric use for Liposorber Apheresis System (FDA)
  • 24 Hour Summary Posted for Circulatory System Devices Panel (FDA)
  • FDA OKs clinical trial for Neuros Medical's pain implant (Mass Device) (MedCity News)
  • Crospon Receives FDA Clearance for EsoFLIP Dilation Catheter (Press)
  • FDA Clears ViSi Mobile System for Cuffless, Non-Invasive Continuous BP Monitoring (MedGadget) (MedCity News)
  • Mobius Imaging Receives FDA Approval for Airo Mobile Intraoperative CT (MedGadget)

US: Assorted And Government

  • A Solution to Regulatory Delay: End Centralized White House Regulatory Review (Huffington Post)
  • TPP Will Not Hinder Access To Essential Medicines, U.S. Commerce Secretary Says (KFF)

Upcoming Meetings And Events

  • 9-10 October 2013: AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings (AAMI)
  • 16 October 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • ENVI Posts Text of Medical Device Directive Overhaul (ENVI)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 October 2013 (EMA)
  • EMA to Host Upcoming Workshop on Biosimilars (EMA)
  • EU guideline revamp to clarify pediatric drug development rules (SCRIP-$)
  • PRAC confirms that benefits of all combined hormonal contraceptives (CHCs) continue to outweigh risks (EMA)
  • Five years later, Europe reinstates aprotinin (SCRIP-$)
  • Preventice Receives European Approval for BodyGuardian Cardiac Monitoring System (MedGadget)

Asia

Other International

  • Health Canada switching to electronic delivery of medical device licenses (Mass Device)
  • New report details scope of counterfeit drugs worldwide (DSN)
  • TGA Issues Warning on Lariam (Mefloquine HCl), Says it can Cause 'Visual Disturbances' (TGA)
  • Innovation, Partnership Necessary To Bring Vaccines To The Poor (KFF)

General Regulatory And Interesting Articles

  • Scientists threatened by demands to share data (Aljazeera)

Regulatory Reconnaissance #176 - 11 October 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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