Regulatory Focus™ > News Articles > Regulatory Reconnaissance (9 October 2013)

Regulatory Reconnaissance (9 October 2013)

Posted 09 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

In Focus: International

  • Scottish drug approval process to be revamped (Pharma Times) (RPS) (PharmExec)
  • Chinese vaccine company wins WHO regulatory approval (Financial Times-$) (WHO)
  • CJEU borderline ruling: easy route out for authorities, bad news for industry and patients (Clinica-$)
  • "Don't import NZ medicines system," warns Medicines Australia (Pharma Letter-$)
  • Assorted Thoughts on Drug Regulatory Developments in South Africa (DrugWonks)

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

US: Pharmaceuticals/Biotechnology

  • Bayer gets US nod for first-in-class Adempas (FDA) (PMLive) (Bayer) (Forbes) (Reuters) (BioCentury) (Fierce) (SCRIP-$) (Pharma Letter-$)
  • FDA places partial clinical hold on Ariad cancer drug trials (Reuters) (The Street) (Fierce) (Bloomberg)
  • Maine to Allow Prescription-Drug Imports (WSJ-$)
  • Teva sees obstacles to copying GSK's Advair drug before 2018 (Reuters)
  • Calif. Gov. Signs Compounding Pharmacy Oversight Bill (Law 360-$)
  • FDA and Industry Priorities Do Not Always Match Up (CHC)
  • BioDelivery Sciences Announces FDA Acceptance of Bunavail NDA for Filing (Press)
  • FDA Accepts Zerenex New Drug Application (PharmPro) (SCRIP-$) (BioCentury)
  • Alkermes Announces Alignment with FDA on Plans for Pivotal Program for ALKS 5461 for Major Depressive Disorder (Press) (Fierce)
  • Pfizer Antibiotic Clindamycin Phosphate Experiencing Drug Shortages (FDA)
  • QRx Pharma gets FDA inputs on Moxduo  (BioSpectrum)
  • Mixed Results for Pfizer's Tofacitinib in two Phase III trials (Press)

US: Medical Devices

  • FDA panel narrowly recommends expanding indication for Medtronic pacemakers (Mass Device) (Gray Sheet-$) (MedPage Today) (Reuters)
  • Robot Surgery Damaging Patients Rises With Marketing (Bloomberg)
  • Long Road To Unique Device Identification: FDA's 'Mr. UDI' Offers Peek Behind Curtain (Silver Sheet-$)
  • Summary: CDRH Details Relaxed Data Standard for IDEs for Early Feasibility Studies (FDA Law Blog)
  • FDA Publishes Three Warning Letters to Device Manufacturers (FDA) (FDA) (FDA) (Law 360-$)
  • Unaccountable Healthcare: Underreporting of Robotic Surgery Problems (MedPage Today)
  • Recall Effectiveness Checks: FDA Tips (Silver Sheet-$)
  • Medical groups warn change to maintenance standards would lead to higher risk (The Hill)
  • Tyber Medical Receives 510 (k) Clearance For TyPEEK And PEEK Interbody Systems (Press)
  • Recall: Edwards Lifesciences pulls EMBOL-X devices over deformed tips (Mass Device)
  • Recall: Fabius Anesthesia Machines for Failed Voltage Testing (FDA) (FDA)

US: Assorted And Government

  • Gov't Shutdown: A Setback For FDA's Momentum (Law 360-$)
  • Survey: U.S. gov't shouldn't have power to weigh costs of new treatments (MedCity News)
  • Dystrophy association, Quintiles make patient registry (BioSpectrum)

Upcoming Meetings And Events

  • October 8-9, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 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

  • Scottish drug approval process to be revamped (Pharma Times) (RPS) (PharmExec)
  • How a marriage between big pharma and academic ended in divorce (BMJ)
  • CJEU borderline ruling: easy route out for authorities, bad news for industry and patients (Clinica-$)
  • Researchers from Germany's Institute for Quality and Efficiency in Health Care call today for clinical study reports (CSRs) from clinical trials to be made publicly available. (AllTrials)
  • GSK planning EMA submission for malaria vaccine (BioCentury)

Asia

  • India: DCGI order on submission of safety data of FDCs challenged in Punjab & Haryana HC (PharmaBiz)
  • Chugai submits Japanese NDA for alectinib (BioCentury)

Other International

  • "Don't import NZ medicines system," warns Medicines Australia (Pharma Letter-$)
  • Chinese vaccine company wins WHO regulatory approval (Financial Times-$) (WHO)
  • Assorted Thoughts on Drug Regulatory Developments in South Africa (DrugWonks)

Regulatory Reconnaissance #174 - 9 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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