Regulatory Focus™ > News Articles > Regulatory Reconnaissance (18 September 2013)

Regulatory Reconnaissance (18 September 2013)

Posted 18 September 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

In Focus: US

  • FDA to review AZ fish-oil heart drug Epanova (Pharma Times) (Pharma Letter) (Reuters) (AZ)
  • Lawmakers, hospitals press OMB on unique identifier rule (Fierce)
  • Suspected human hair in tablet cited in FDA's Ranbaxy import ban (Reuters)
  • FDA Official: Agency Will More Aggressively Push For Subgroups In Trials (IHP)
  • FDA Issues Wave Of "Breakthrough Therapy" Denials (RPM Report)
  • Agencies eye Twitter for help writing regulations (The Hill)

In Focus: International

  • ENVI vote postponed (and why that's a good thing for industry) (Clinica) (MedDevices Legal) (ENVI) (Fierce)
  • Sanofi's MS Drug Lemtrada Receives Approval in Europe (WSJ) (BioCentury)
  • Dendreon's cancer vaccine Provenge wins EU approval (PMLive) (SCRIP) (BioCentury)
  • Health Canada Adopts ICH E2C Document on PBRERs (HC)
  • 'We need pharma-style IP protection,' says leading Australian supplements player (NI)

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

US

Pharmaceuticals/Biotechnology
  • FDA to review AZ fish-oil heart drug Epanova (Pharma Times) (Pharma Letter) (Reuters) (AZ)
  • Suspected human hair in tablet cited in FDA's Ranbaxy import ban (Reuters)
  • National Strategy For Biomedical Innovation Simmering On Hamburg's Agenda (Pink Sheet)
  • FDA Official: Agency Will More Aggressively Push For Subgroups In Trials (IHP)
  • U.S. Bid To Extend Drug-Patent Term In TPP Nations Meets Resistance (PharmAsia)
  • FDA Approves New Liquid Formulation of Teva's Treanda (bendamustine HCI) Injection (Teva)
  • FDA Issues Wave Of "Breakthrough Therapy" Denials (RPM Report)
  • List of all Currently-Granted Breakthrough Therapies (Burrill Report)
  • The Omniscient Regulator: QRxPharma's Unusual Take on FDA and Investor Calls (RPM Report)
  • FDA approves Lupin's generic version of Ambien CR (DSN)
  • Eslicarbazepine meets in pair of Phase III seizure trials (BioCentury) (Pharma Letter)
  • Somatuline Autogel meets in Phase III for carcinoid syndrome (BioCentury)
  • Hospira recalls bupivacaine because of steel particles in vials (Fierce)
  • Guantánamo Bay Force-Feeding Petition Highlights FDA's Role As Political Football (Pink Sheet)
  • Chronic Kidney Disease Drug Gets a Name (DD&D)
  • Shares jump for Agenus on successful brain cancer vaccine trial (Reuters)
  • Ipsen hopes study results could lead to additional Somatuline indication (Pharma Letter)
  • New study finds no greater depression risk for those using Chantix to quit smoking (Reuters)
  • Supreme Court Asked To Weigh Hospira Drug-Shortage Suit (Law 360)
  • GlaxoSmithKline terminates Crohn's drug program following a pivotal failure (Fierce)
  • California Proposes Breakthrough ePedigree Regulation On Drop Shipments (RxTrace)
Pharmaceuticals and Biotechnology: General
  • Undisclosed Conflicts: A Blemish On Acne Treatment Guidelines? (Pharmalot) (JS)
  • Covering Breakthroughs: Payors in New Territory (RPM Report)
Medical Devices
  • Lawmakers, hospitals press OMB on unique identifier rule (Fierce)
  • HeartSine recalls public access defibrillators (Cardiovascular Business) (FDA)
  • Error Proofing with eDHR: A Strategic Solution for Medical Device Manufacturers (Manufacturing Geek)
  • Boston Scientific Reports Favorable Six-Month Results from Lotus Valve System Clinical Trial (BSC)
Assorted And Government
  • Details Lacking on Prescription Drug Coverage in New Health Law (NYTimes)
  • How one woman helped prevent a health crisis in the US (PMLive)
  • OMB Signs off on FDA Guidance on PET Drugs, Orphan Drugs, and Pediatric Medical Devices (OMB)
  • Enhancing Racial Diversity in Clinical Trials (PharmExec)
  • Agencies eye Twitter for help writing regulations (The Hill)
  • BioPQQ Successfully Filed as NDI (NPI)
Upcoming Meetings And Events
  • 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 18 25 September 2013: ENVI Meeting on Medical Device Proposals (ENVI)
  • 19 September 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19-20 September 2013: Pediatric Advisory Committee Meeting  (FDA) (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

Asia

Other International

  • Health Canada Adopts ICH E2C Document on PBRERs (HC)
  • 'We need pharma-style IP protection,' says leading Australian supplements player (NI)
  • Regulators publish list of medical devices exempt from regulation in Peru (Mass Device)

General Regulatory And Interesting Articles

  • Patients have a right to participate in risky research (MNT)

Regulatory Reconnaissance #157 - 18 September 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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