Regulatory Focus™ > News Articles > Regulatory Reconnaissance (23 September 2013)

Regulatory Reconnaissance (23 September 2013)

Posted 23 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.

Editor's Note: I'm at the AdvaMed 2013 conference today, so regular news updates are unlikely.

In Focus: US

  • How Wall Street uses FOIA Requests to Probe FDA for Industry Problems (WSJ) ($)
  • FDA To Close Office In Amman, Jordan; Operations Moving To White Oak (Pink Sheet) ($)
  • Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection (Merck)
  •  "Breakthrough" Therapy Designation Comes With Resource Demands For Sponsors (Pink Sheet) ($)
  • UDI And The Approaching End Of The NDC (RxTrace)
  • Being Unprepared For Compliance Meetings With FDA Can Lead To Tense Moments, Ex-CDRH Leaders Say (Gray Sheet) ($)

In Focus: International

  • EucoMed: ENVI is Rushing Through Medical Device Amendments (EurActiv)
  • EMA's Heralded Revamp May Be Hampered By Tight Budget And Staffing (Pink Sheet) ($)
  • UK Reverses Swine Flu Vaccine-Narcolepsy Decision (Scientific American)
  • Drugmaker USV pulled up by USFDA for data fudging (India Times)
  • CFDA Seeks Public Views On Rule For Punishing Drug-Law Offenders (PharmAsia) ($)

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

US: Pharmaceuticals/Biotechnology

  • Pfizer launches trial data sharing service (Pharmafile)
  • Mini-Sentinel Prospective Surveillance Program Can Assist New Drug Pharmacovigilance (Pink Sheet) ($)
  • "Breakthrough" Therapy Designation Comes With Resource Demands For Sponsors (Pink Sheet) ($)
  • Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection (Merck)
  • Mylan Weighs in on Biosimilar Naming Debate (Mylan)
  • Antibiotic Development: As FDA's QIDP List Grows Longer, Will Firms GAIN Less? (Pink Sheet) ($)
  • When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment (SSRN)
  • UDI And The Approaching End Of The NDC (RxTrace)
  • Stelara (ustekinumab) Receives FDA Approval To Treat Active Psoriatic Arthritis (Janssen)
  • Teva's exclusive launch of generic Niaspan in the USA (Pharma Letter) ($)
  • US issues injunction against Hanmi's NDA  (BioSpectrum)
  • Glenmark gets USFDA nod for generic Desoximetasone ointment (India Times)

US: Pharmaceuticals and Biotechnology: General

  • Massachusetts to Soon Hold Hearing on Discharge of Pharmaceutical-laden Wastewater (Scout)

US: Medical Devices

  • CDRH Bringing Patients Into the Process (FDA)
  • CDRH Office Of Compliance Shifts To "Function-Based Structure" (Gray Sheet) ($)
  • Being Unprepared For Compliance Meetings With FDA Can Lead To Tense Moments, Ex-CDRH Leaders Say (Gray Sheet) ($)
  • Industry Asks FDA To Relay Study Design Concerns Separately From IDE Decisions (Gray Sheet) ($)

US: Assorted And Government

  • How Wall Street uses FOIA Requests to Probe FDA for Industry Problems (WSJ) ($)
  • FDA To Close Office In Amman, Jordan; Operations Moving To White Oak (Pink Sheet) ($)
  • HHS makes last-minute changes to HIPAA privacy rule (Modern Healthcare) ($) (HITS)
  • US Capitol Capsule: Sequester ignored in shutdown chicken game; researchers continue fight (SCRIP) ($)
  • How Many Die From Medical Mistakes In U.S. Hospitals? 210,000 to 440,000 each year. (NPR)

Upcoming Meetings And Events

  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: ENVI Meeting on Medical Device Proposals (ENVI)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)

Europe

  • EucoMed: ENVI is Rushing Through Medical Device Amendments (EurActiv)
  • EMA's Heralded Revamp May Be Hampered By Tight Budget And Staffing (Pink Sheet) ($)
  • CMDh Recommends Suspending MAA for Numeta G13%E due to Hypermagnesaemia Risk (EMA)
  • UK Reverses Swine Flu Vaccine-Narcolepsy Decision (Scientific American)
  • LabStyle Innovations Receives CE Mark for Its Dario Smartphone-Based Diabetes Management System (LabStyle)

Asia

  • Drugmaker USV pulled up by USFDA for data fudging (India Times)
  • CFDA Seeks Public Views On Rule For Punishing Drug-Law Offenders (PharmAsia) ($)
  • Wockhardt taking steps to firm up manufacturing processes (India Times)
  • UK, Australia regulators seek details of US findings on Ranbaxy's Mohali plant (India Times)
  • BA/BE studies of new drugs discovered abroad & not marketed in India should not be approved to be conducted in India: Panel (PharmaBiz)

General Regulatory And Interesting Articles

  • Risk-Based Monitoring and the Implications to Data Management (Geeks Talk Clinical)
  • Did Antidepressant Play a Role in Navy Yard Massacre? (Scientific American)
  • Captain Zantac To The Rescue! Animated Mascots Return To Promote Heartburn Relief (Forbes)

Regulatory Reconnaissance #161 - 23 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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