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

Regulatory Reconnaissance (18 December 2013)

Posted 18 December 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.

Your editor will be on break for the Holiday starting 21 December 2013, and returning on 2 January 2014. Regulatory Reconnaissance will not be published during this time.

In Focus: US

  • FDA's Sherman leaving as OMP director (BioCentury)
  • Drugmakers urge FDA security audit after cyber breach (Reuters) (Pharmafile)
  • Teva will sell generic Viagra in US starting December 2017 (SCRIP-$) (Reuters) (Press) (Pharma Times) (AP)
  • Drug Safety Forecast: Greater Understanding Could Signal Fewer Withdrawals (PAM-$)
  • Usability Testing In FDA's Crosshairs As Manufacturers Seek Human Factors Buy-In (Silver Sheet-$)
  • Parallel Review Expands. But Will It Get More Participants? (Bloomberg BNA)

In Focus: International

  • Statements of non-compliance with GMP now publicly available in EudraGMDP (EMA)
  • European Medicines Agency now publishing meeting agendas for all scientific committees (EMA)
  • EU plans to modernize trade mark system include protection for generics in transit (SCRIP-$)
  • Pharma chief: Governments must stop thinking short-term to save industry (EurActiv)
  • Novartis May Face Criminal Charges In Japan Over Diovan Research (Pharmalot) (India Times)

US: Pharmaceuticals/Biotechnology

  • FDA's Sherman leaving as OMP director (BioCentury)
  • Drugmakers urge FDA security audit after cyber breach (Reuters) (Pharmafile)
  • Teva will sell generic Viagra in US starting December 2017 (SCRIP-$) (Reuters) (Press) (Pharma Times) (AP)
  • Drug Safety Forecast: Greater Understanding Could Signal Fewer Withdrawals (PAM-$)
  • Experts Applaud FDA Plan on Antibiotic Soaps (MedPage Today)
  • FTC reschedules biosimilar meeting (BioCentury)
  • Painful Erections: Another Reason To Worry About ADHD Pills (Pharmalot) (FDA) (FDA) (Pharma Times) (Reuters) (MedPage Today)
  • FDA disapproves Sun Pharma unit's product in present form (India Times)
  • Hanmi launches esomeprazole product in USA despite AstraZeneca litigation (Pharma Letter-$) (PMLive) (Press)
  • Lupin launches HIV drug in the US with marketing exclusivity (India Times)
  • Managing Off-Label Drug Use (Health Affairs)
  • Ariad Took Dismissive View Of CV Events In Iclusig Labeling Proposals (PAM-$)
  • Side Effects May Include Death: The Story Of The Biggest Advance In Birth Control Since The Pill (Huffington Post)
  • Ranbaxy Seeks Allies On Valsartan Market Exclusivity To Comply With FDA Manufacturing Requests (Pink Sheet-$)
  • Whatever Happened To The ADA Request For Data From Pharma? (Pharmalot)
  • Pfizer Pay-For-Delay Claims Get 2nd Chance (Law 360-$)
  • GSK's Focuses Bioelectronics Quest On Blocking Single-Organ Neural Signals (Pink Sheet-$)

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

  • Priority Review for Arzerra from GSK, Genmab (BioCentury) (Press)
  • Ipsen reports positive Phase III results for Dysport in adult upper limb spasticity (Pharma Letter-$)
  • Amgen reports positive results from Phase III trial of evolocumab for high cholesterol (Pharma Letter-$) (SCRIP-$) (Fierce) (Press) (BioCentury)
  • Gilead Announces SVR12 Rates From Three Phase 3 Studies Evaluating a Once-Daily Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients (Press)
  • Onconova tanks as its lead candidate flunks PhIII for pancreatic cancer (Fierce) (BioCentury)
  • FDA Grants Orphan Drug Designation to Omeros' OMS721 for Complement-Mediated Thrombotic Microangiopathies (Press)
  • InSite Vision Announces Positive Confirmatory Phase 3 Results for BromSite™ for the Reduction of Inflammation and Pain after Cataract Surgery (Press)

US: Pharmaceuticals and Biotechnology: General

  • Drug Firms Curb Ties to Doctors (WSJ-$)
  • Glaxo Announcement Won't End Biomedicine's Conflicts of Interest (Scientific American)
  • Behind The Curtain: Study Reveals Big Role of Medical Communication Companies (Forbes)

US: Medical Devices

  • Usability Testing In FDA's Crosshairs As Manufacturers Seek Human Factors Buy-In (Silver Sheet-$)
  • Parallel Review Expands. But Will It Get More Participants? (Bloomberg BNA)
  • Abbott Issues Class 1 Recall for Glucose Test Strips (FDA) (FDA)
  • Do The 'Write' Thing For Device Documents (Silver Sheet-$)
  • Overview of Medical Device Classification and Reclassification (FDA)
  • Transcript: Design Considerations for Pivotal Clinical Investigations for Medical Devices (FDA)
  • Paragonix makes FDA bid for Sherpa kidney, heart transportation systems (Mass Device)
  • Oticon Medical Receives FDA Clearance to Market New Ponto Plus Bone Anchored Sound Processors in Regular and Power Versions (Press)
  • Class 1 Recalls for Nephros Products (FDA) (FDA) (FDA)

US: Dietary Supplements

US: Assorted And Government

  • PCORI Approves $191 Million to Support Patient-Centered Comparative Effectiveness Research (PCORI) (PCORI) (BioCentury)
  • FDA Confers with International Counterparts to Advance Regulatory Science (FDA)
  • Gates Foundation Gets UCSF Chief Desmond-Hellmann as New CEO (Xconomy)
  • One way everyone can help with post-market surveillance of medical devices and drugs (MedCity News)
  • FDA Looking to Hire a New Director for its Office of Applied Research and Safety Assessment, CFSAN (FDA)
  • Lawmakers press regs office to clean up act (The Hill)

Upcoming Meetings And Events

  • 17 December 2013: Risk Communication Advisory Committee Meeting (FDA)
  • 10 January 2013: National Biodefense Science Board Meeting (DHHS)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Statements of non-compliance with GMP now publicly available in EudraGMDP (EMA)
  • European Medicines Agency now publishing meeting agendas for all scientific committees (EMA)
  • EU plans to modernize trade mark system include protection for generics in transit (SCRIP-$)
  • Pharma chief: Governments must stop thinking short-term to save industry (EurActiv)
  • European Medicines Agency's Management Board endorses work programme 2014 (EMA)
  • Denmark backs generic lung drug in threat to GSK sales (Reuters)
  • At a glance: EUnetHTA JA2 Year 1 (EUnetHTA)
  • UK to Allow the Sale of HIV Home Testing Kits (UK DOH)
  • Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates (EMA)

Asia

  • Novartis May Face Criminal Charges In Japan Over Diovan Research (Pharmalot) (India Times)
  • China Looks To Introduce Drug, Device Safety Blacklist System (PharmAsia-$)
  • Japan Women Warned Of Deaths, Serious Effects Of Birth Control Pills (PharmAsia-$)

Other International

  • New president to Brazil's patent and trademark office: what now? (SCRIP-$)

General Regulatory And Interesting Articles

  • How mobiles make clinical trials bigger, faster and more efficient (MobiHealth News)
  • Predictive modeling can flag potential candidates for clinical trials (Fierce)
  • Kids' coughs, colds may last weeks but don't need drugs (Reuters)

Regulatory Reconnaissance #224 - 18 December 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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