Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Weekend Edition (7-8 September 2013)

Regulatory Reconnaissance: Weekend Edition (7-8 September 2013)

Posted 06 September 2013 | By Alexander Gaffney, RAC

Welcome to a special weekend edition of Regulatory Reconnaissance, Focus' regulatory news and intelligence briefing. We're back in action after our series of four-day weeks this summer and ready to get you in fighting form for the fall.

In Focus This Week in Regulatory Focus

  • FDA Looks to Help Device Industry by Increasing Speed, Transparency of Interim Regulatory Guidance (Focus)
  • Facing Myriad Challenges, FDA Forms New Workgroup to Reposition Agency for Future (Focus)
  • FDA's Office of Regulatory Affairs Announces Appointment of Permanent Director (Focus)
  • Human Rights Group to FDA: Reglan Needs New Restrictions, REMS to Prevent Use at Guantanamo Bay (Focus)
  • ICH Lays Out Roadmap for Exempting Certain Studies from Rodent Carcinogenicity Testing (Focus)
  • ONC Issues Recommendations for FDA's Mobile Health Regulation Framework (Focus)
  • As Revised Declaration of Helsinki Advances, Industry Left Waiting to See Changes (Focus)

In Focus: US

In Focus: International

  • ANALYSIS: Approvals up YoY as IVDs win again (Clinica)
  • A Closer Look: Did Roche Exhaust Its Options On Herceptin India Patents? (PharmAsia)
  • China's 1st Step Toward More Participation In Rulemaking (Law 360)

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  • FDA approves Abraxane for late-stage pancreatic cancer (FDA) (Reuters) (Celgene)
  • FDA staff plugs efficacy of projected COPD blockbuster from GSK and Theravance, but says data missing (Fierce) (Reuters) (Law 360) (Bloomberg) (SCRIP)
  • Bicameral, Bipartisan Talks Keep Drug Compounding In Focus During Recess (IHP)
  • FDA Grants Tenative Approval to Mylan's Rasagiline Mesylate (Brand: Azilect) (FDA)
  • Federal judge grants FDA request for consent decree with Idaho farm (FDA)
  • Hospira to Discontinue Manufacture Phenytoin Sodium Injection (FDA)
  • Positive data on RVX-208 pushes Resverlogix shares higher (Pharma Letter)
  • Avanir Pharmaceuticals Announces Settlement of Nuedexta Patent Litigation with Wockhardt (Avanir)
Medical Devices
  • Medtronic: Rented surgical kit may have been contaminated with fatal brain disease (Mass Device) (Boston Globe) (Mass Device)
  • FDA: The path toward a risk-based regulatory framework for health IT (FDA)
  • Prosecutors say DePuy hid risks in ASR hip recall (Mass Device)
  • Meetings: Circulatory System Devices Panel of the Medical Devices Advisory Committee to Discuss Heart Failure Devices (FDA)
  • August 2013 510(k) Clearances (FDA)
  • J&J kicks off $5 billion clinical diagnostics unit sale: sources (Reuters)
Assorted And Government
  • NIH launches first national Down syndrome registry (NIH)
  • National Toxicology Program Publishes Technical Reports (NTP)
  • Rulemaking 2.0: Understanding and Getting Better Public Participation (IBM)
  • Implications of the August 20 OMB Report on FDA (Strengthen FDA)
  • NIH grants to investigate disease-related variations in genetic makeup (NIH)
Upcoming Meetings And Events
  • 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 18 September 2013: ENVI Meeting, no Known Agenda as of Yet (ENVI)
  • 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)


  • ANALYSIS: Approvals up YoY as IVDs win again (Clinica)
  • Pharmacovigilance Risk Assessment Committee meeting highlights (Pharma Letter)
  • Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use September 2013 (EMA)


  • A Closer Look: Did Roche Exhaust Its Options On Herceptin India Patents? (PharmAsia)
  • China's 1st Step Toward More Participation In Rulemaking (Law 360)
  • Would GSK pull out of China altogether? (Fierce)
  • 'Long and tortured' Asean supplement harmonisation process making steady progress (NI)

General Regulatory And Interesting Articles

  • Researchers Claim to Successfully 3D-Print Living Kidneys (MedGadget)
  • Birth rate for teenagers reaches new low in U.S. (CBS)

Regulatory Reconnaissance #148  - 7-8 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

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