Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Weekend Edition (28-29 September 2013)

Regulatory Reconnaissance: Weekend Edition (28-29 September 2013)

Posted 27 September 2013 | By Alexander Gaffney, RAC

Welcome to a special weekend edition of Regulatory Reconnaissance, Focus' regulatory news and intelligence briefing. Are you going to be in Boston for the 2013 RAPS conference on Monday, Tuesday or Wednesday? So will we! Come say "Hello" if you see us!

Comments? Suggestions? Email me at

US: Pharmaceuticals/Biotechnology

  • FDA warns Pfizer's drug Tygacil raises risk of death (Reuters) (FDA) (FDA) (Pink Sheet) (Public Citizen)
  • Massachusetts Biosimialars Legislation Moves Forward (Scout)
  • Industry Asks FDA to Clarify How Current CMC Submission Paradigm Can Flex to Accommodate Breakthrough Therapy Development Timelines (IPQ)
  • Contamination and Raw Material Testing Issues Raised in 2013 FDA Warning Letters (Gold Sheet)
  • U.S. FDA India Head Will Push For Preventive Controls in Manufacturing Processes (Gold Sheet)
  • FDA Wants To Know "Who's On First" In Contract Manufacturing Quality Agreements (Gold Sheet)
  • U.S. Protectionism: An Increasing Barrier to Foreign-based Drug Manufacturers (Porzio)
  • FDA Posts Update on Pharmaceutical Compounder, Warns of "Visible, Floating Material" (FDA)
  • Apprehension Builds as FDA Aims to Get its Quality Initiative Right the Second Time (Gold Sheet)
  • Expert Workshop: Strengthening Risk Evaluation and Mitigation Strategies (REMS) Through Systematic Analysis, Standardized Design, and Evidence-Based Assessment (Brookings)
  • Zalicus' Z160 Receives Orphan Drug Designation for the Management of Postherpetic Neuralgia (Press)
  • FDA Approves New Dosing Option for CSL Behring's Hizentra (Press)

US: Pharmaceuticals and Biotechnology: General

  • A PHI dilemma: DEA and prescription drug abuse monitoring (GovHealthIT)

US: Medical Devices

  • U.S. approves first artificial pancreas system for diabetics (Reuters) (Mass Device) (Fierce) (MedGadget)
  • InterFuse L Modular Implant from Vertebral Technologies Receives FDA 510(k) Clearance (MedGadget)
  • Medtronic details diabetes facility warning letter (Mass Device)

US: Assorted And Government

  • What Happens at FDA in a Shutdown? (Strengthen FDA)
  • FDA's Patient Skills: One Year Later (RPM Report)
  • Confluence of Symptoms and Treatments at FDA Patient Meetings (RPM Report)
  • Sen. King makes case for opposing 'dumb' regulations (The Hill)

Upcoming Meetings And Events

  • 29 Sept. - 2 Oct. 2013: 2013 RAPS Regulatory Convergence (RAPS)
  • 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)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • NICE draft guidance recommends two, rejects three ovarian cancer drugs (SCRIP) (Pink Sheet) (Fierce)
  • Eucomed comes out all guns blazing as MEPs admit changes needed to reg tex (Clinica)
  • AllTrials response to EMA consultation on access to clinical trial data (AllTrials) (SCRIP)
  • UK to extend cancer drugs fund? (SCRIP)


  • Forget The Apology: Japan To Raid Novartis Offices Over Diovan Scandal (Pharmalot)
  • Takeda Submits TAK-816 NDA in Japan (DD&D)

General Regulatory And Interesting Articles

  • Immune drugs hold hope of "clinical cure" for deadly skin cancer (Reuters)
  • Average Phase I Trial Costs Approach $9,000 Per Patient Per Month (Press)
  • Geek Video of the Week: 4D Printing and Manufacturing (Manufacturing Geek)

Regulatory Reconnaissance #166 - 28 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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