Regulatory Focus™ > News Articles > Regulatory Reconnaissance: US, EU Team up in New Pharmacovigilance Initiative (20 February 2014)

Regulatory Reconnaissance: US, EU Team up in New Pharmacovigilance Initiative (20 February 2014)

Posted 20 February 2014 | By Alexander Gaffney, RAC 

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In Focus: US

  • EMA and FDA create pharmacovigilance 'cluster' (PMLive) (SCRIP-$) (FDA) (In-Pharma) (BioCentury) (EMA)
  • FDA faces regulatory challenges with new approaches to medicine (BMJ-$)
  • Critics Decry Unbranded Marketing of Vanda's new Sleep Drug for the Blind (Boston Herald)
  • Roche May Share Trial Data on Avastin Amid Brain Cancer Conflict (Bloomberg)
  • FDA reviews adverse events, durability of Inspire Medical's sleep apnea implant (Mass Device)
  • HeartSine warned by FDA over progress addressing defibrillator recall (Fierce)

In Focus: International

  • Not transposing FMD could land Ireland, Italy, Poland and Slovenia in court says EC (In-Pharma)
  • Majority of EU member states say 'no' to INNs for biosimilars (BioPharma Reporter)
  • GSK's Anoro gets Positive CHMP Opinion (Press) (Reuters)
  • ACRO warns on Indian clinical-trial regulations (Pharma Times)
  • India focuses on cell therapy regulation as FDA's Hamburg wraps up trip (Biopharma Reporter)
  • DCGI Proposes Requiring Drug Maker Post-Marketing Monitoring Units (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • EMA and FDA create pharmacovigilance 'cluster' (PMLive) (SCRIP-$) (FDA) (In-Pharma) (BioCentury) (EMA)
  • FDA faces regulatory challenges with new approaches to medicine (BMJ-$)
  • Critics Decry Unbranded Marketing of Vanda's new Sleep Drug for the Blind (Boston Herald)
  • US v. Caronia, One Year Later: FDA's Position on Off-Label Promotion Remains the Same, But Changes are Looming (Policy and Medicine)
  • Antibiotic Development Incentives Face Critical Test As NDA Reviews Begin (PAM-$)
  • FDA Review Of GE's Vizamyl Shows Caution In The Face Of Alzheimer's Disease Unknowns (PAM-$)
  • Agila Specialties Private Limited Initiates Voluntary Nationwide Recall of 10 Lots of Etomidate Injection due to the Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date (FDA)

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

  • Onconova hammered after top drug rigosertib flunks key PhIII study (Fierce) (SCRIP-$)
  • Teva dropping Phase III laquinimod trial (BioCentury)
  • FDA Accepts for Review Merck's Biologics License Application for V503, Investigational 9-valent Human Papillomavirus Vaccine (Press)
  • First-line use of bevacizumab does not improve overall survival in patients with newly diagnosed glioblastoma (NEJM) (Press)
  • Roche May Share Trial Data on Avastin Amid Brain Cancer Conflict (Bloomberg)

US: Pharmaceuticals and Biotechnology: General

  • DQSA: How Should Transaction Data Be Exchanged? (RxTrace)

US: Medical Devices

  • FDA reviews adverse events, durability of Inspire Medical's sleep apnea implant (Mass Device)
  • HeartSine warned by FDA over progress addressing defibrillator recall (Fierce)
  • 2013 Year in Review: CDRH Promotion and Marketing Enforcement Letters (King & Spalding)
  • FDA Issues Final Rule and Guidance on Electronic MDR Reporting (FDA Law Blog)
  • FDA clears Carestream's imaging app for Apple and Samsung devices (MobiHealthNews)
  • Admedus gains U.S. clearance for cardiovascular scaffold (Mass Device)
  • Philips Respironics Initiates Recall of Trilogy Ventilator (FDA)

US: Assorted And Government

  • Obama orders 2016 deadline for 'single-window' import/export system (SCRIP-$)
  • New Cyberthreat Report By SANS Institute Delivers Chilling Warning To Healthcare Industry (Forbes)
  • Cardiologist Victor Dzau to lead IOM (Cardiovascular Business)
  • House GOP plots anti-reg blitz (The Hill)

Upcoming Meetings And Events

  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Not transposing FMD could land Ireland, Italy, Poland and Slovenia in court says EC (In-Pharma)
  • Majority of EU member states say 'no' to INNs for biosimilars (BioPharma Reporter)
  • European Medicines Agency to approach GSK after respiratory pharmacists raise concerns about Relvar Ellipta (PJO)
  • NICE wants more Tecfidera data (BioCentury)
  • GSK's Anoro gets Positive CHMP Opinion (Press) (Reuters)
  • Medtronic lands U.S., E.U. wins for miniature cardiac monitor (Mass Device) (Fierce)
  • Shire makes decentralized EU filing for Elvanse for adults (SCRIP-$)
  • Lessons learned from the review of the labelling of centrally authorised pandemic vaccines (EMA)
  • Cell-based products dominate advanced therapy pipeline in EU (SCRIP-$)
  • Medicine shortages are not all due to exports, conference hears (PJO)

India

  • ACRO warns on Indian clinical-trial regulations (Pharma Times)
  • India focuses on cell therapy regulation as FDA's Hamburg wraps up trip (Biopharma Reporter)
  • DCGI Proposes Requiring Drug Maker Post-Marketing Monitoring Units (PharmAsia-$)
  • Déjà Vu: PhRMA, IPA At Loggerheads Again Over India's IP Laws (PharmAsia-$)

Japan & China

  • Chinese bribery crackdown far from over (SCRIP-$)

Other International

  • PIC/S revises Annex 14 for Medicinal Products derived from Human Blood or Plasma (ECA)
  • PIC/S GMP Guideline - Revised Annex 2 for biological Substances and Products adopted (ECA)

General Regulatory And Interesting Articles

  • WHO reports success in distributing vaccines at ambient temperatures (Fierce) (Scientific American) (IRIN)
  • Informed Consent for Pragmatic Trials - The Integrated Consent Model (NEJM)

Regulatory Reconnaissance #260 - 20 February 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.


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