Regulatory Focus™ > News Articles > Regulatory Reconnaissance (8 October 2013)

Regulatory Reconnaissance (8 October 2013)

Posted 08 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

  • Everything You Need to Know About FDA During the Federal Government Shutdown (FDA)
  • House passes FDA carve out (BioCentury) (SCRIP-$) (The Hill) (Mass Device)
  • FDA plans surprise inspections at Indian drug units (LiveMint)
  • GSK's Malaria Vaccine Hits PhIII Trial Endpoints, Filing Planned for Next Year (GSK) (Pharma Letter-$) (NPR) (Reuters) (WSJ) (PMLive)
  • Compounding/Track And Trace Bill Another Victim Of Shutdown (Pink Sheet-$)
  • FDA: Medtronic, CardioMEMS panel reviews are on despite government shutdown (Fierce)
  • FDA LASIK Studies Delayed by 'War Efforts' (MDDI)

In Focus: International

  • GHTC Launches New tool to understand global health regulatory requirements (GHTC) (Site)
  • European Medicines Agency's Management Board supports plan to publish agendas and minutes of all committees (EMA)
  • Christa Wirthumer-Hoche new Head of the Austrian Medicines Agency (AGES)
  • Japanese lawmakers are stepping in to Diovan investigation (Pharma Letter-$)

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

US: Pharmaceuticals/Biotechnology

  • Everything You Need to Know About FDA During the Federal Government Shutdown (FDA)
  • FDA plans surprise inspections at Indian drug units (LiveMint)
  • GSK's Malaria Vaccine Hits PhIII Trial Endpoints, Filing Planned for Next Year (GSK) (Pharma Letter-$) (NPR) (Reuters) (WSJ) (PMLive)
  • Compounding/Track And Trace Bill Another Victim Of Shutdown (Pink Sheet-$)
  • Biogen Says Death of MS Patient Not Related to Tecfidera (WSJ) (Fierce)
  • What Happens to Patent Terms, 180-Day Exclusivity and ANDAs During the Shutdown? (FDA Law Blog)
  • FDA Is Accused Of Attending "Inappropriate" Meetings, But Critics Are Missing Some Key Points (Forbes)
  • Pay-to-play at FDA: A setback for true collaborative efforts (Health Business Blog)
  • Quintiles calls for voluntary, non-public release of masked clinical trial data (Outsourcing Pharma)
  • Biosimilar Naming Petition Stirs Debate Heading Into Key WHO Meeting (IHP-$)
  • FDA Warns of Impending Shortage of Doxil (FDA)
  • J&J's Doxil shortage to last until at least end of 2014 (Fierce)
  • India's MSN Labs Hit with FDA Form 483 (Zach Brennan)
  • CBER workshop victim of shutdown (BioCentury)
  • High Court Won't Mull Punitives In Drug Labeling Suits (Law 360-$)
  • PhRMA calls for regulatory environment to support rare disease research (Pharma Letter-$) (SCRIP-$)
  • New FDA MAPP for the Office of Business Informatics (FDA)
  • Justices Won't Hear Design Defect Suit Over Generic Reglan (Law 360-$)
  • GlaxoSmithKline's Duchenne MD drug mirrors placebo effect in PhIII (Fierce)
  • Navidea Biopharm's Lymphoseek Hits Phase III Endpoints (Press)
  • Novartis' Omalizumab meets in third chronic idiopathic urticarial Phase III trial (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • Rx Drug Abuse Up, States Lax in Curbing It (MedPage Today)
  • Texas says won't return execution drugs to pharmacy facing scrutiny (Reuters)
  • High Court Won't Block Puerto Rico's Control Of Drug Prices (Law 360)

US: Medical Devices

  • FDA: Medtronic, CardioMEMS panel reviews are on despite government shutdown (Fierce)
  • J&J Loses Case Over Ties Between Powder And Ovarian Cancer (Fierce)
  • FDA LASIK Studies Delayed by 'War Efforts' (MDDI)
  • Delcath axes one-third of staff after FDA rejection (Fierce)
  • iHealth gets FDA clearance for medical-grade pulse ox (MobiHealthNews)
  • FDA Clears Innovative Spinal Fusion Device (Press)
  • CIVCO Announces FDA 510(k) Clearance of Protura Robotic Patient Positioning System Integration with Varian Clinac iX and Trilogy Linacs (Press)

US: Assorted And Government

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

  • European Medicines Agency's Management Board supports plan to publish agendas and minutes of all committees (EMA)
  • Christa Wirthumer-Hoche new Head of the Austrian Medicines Agency (AGES)
  • State of play on EU medtech reg: a big, unpalatable stew (Clinica-$)
  • Medtronic touts EU regulatory win, commercial launch of new cervical cage (Mass Device)
  • Adcetris, Zelboraf, Stelara on new EMA list of safety actions (SCRIP-$)

Asia

  • India's Top Court To Consider Recommendations On Clinical Trials Regulation In December (PharmAsia-$)
  • Japanese lawmakers are stepping in to Diovan investigation (Pharma Letter-$)
  • Blacklisted Bliss GVS blames delayed re-registration for 'fake' drug issue in Ghana (SCRIP-$) (Business Ghana)

Other International

  • GHTC Launches New tool to understand global health regulatory requirements (GHTC) (Site)

General Regulatory And Interesting Articles

  • Study seeks to answer medical mystery: Would changes to prescription drug labels boost adherence? (MedCity News)
  • Translational pharmacology and drug dosing (PMLive)
  • The Methiest States In The U.S. (Huffington Post)

Regulatory Reconnaissance #173 - 8 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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