Regulatory Focus™ > News Articles > Regulatory Reconnaissance (27 September 2013)

Regulatory Reconnaissance (27 September 2013)

Posted 27 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 483 to Wockhardt Finds Urine Spills, Dilapidated Buildings (Bloomberg)
  • Money Has a Way of Changing People: The UFAization of FDA's Office of Generic Drugs (FDA Law Blog)
  • Aarti also under FDA lens over GMP deviations at Indian site (SCRIP-$)
  • J&J says more Doxil shortages imminent, tied to Ben Venue problems (Fierce)
  • Baxter axes jobs after FDA warns over pump (Fierce)
  • TAVR Registry Data Triggers Expansion Of FDA-Approved Indication (Gray Sheet-$)
  • Maker of dangerous pain pills is 'ghost' that can't be found (USA Today)

In Focus: International

  • ENVI committee voted through entirely different reprocessing rules yesterday (SCRIP-$)
  • EMA to Hold Meeting on Incentivizing Development of New Antibiotics (EMA) (EMA)
  • UK MHRA mulls new incident reporting system (In-Pharma)
  • Japan to raid local arm of Novartis over alleged data fabrication: Reports (India Times)
  • Novartis issues apology to Japan after drug trial allegations (Reuters)

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

US: Pharmaceuticals/Biotechnology

  • FDA 483 to Wockhardt Finds Urine Spills, Dilapidated Buildings (Bloomberg)
  • Money Has a Way of Changing People: The UFAization of FDA's Office of Generic Drugs (FDA Law Blog)
  • Aarti also under FDA lens over GMP deviations at Indian site (SCRIP-$)
  • Big Pharma And Meth Cooks Agree: Keep Cold Meds Over The Counter (NPR)
  • J&J says more Doxil shortages imminent, tied to Ben Venue problems (Fierce)
  • Drug Security Compromise Omits Third-Party Logistic Provider Tracing Reqs (IHP-$)
  • New Compounding Legislation Calls for Voluntary Registration as "Outsourcing Facility" (E&C) (Modern Healthcare) (Pink Sheet-$)
  • Lilly submitting ramucirumab as gastric cancer combo after breast cancer failure (BioCentury) (RTT) (SCRIP-$) (Pink Sheet-$) (Fierce) (Reuters) (Pharma Times)
  • FDA Awards $2.2 Million to University of Cincinatti to Study Brand-to-Generic Switches in Tacrolimus Products (FDA)
  • BioMarin Holds Firm Against Granting Compassionate Use Exemption for Patient (Huffington Post)
  • Merck gives up on unsuccessful Januvia combo drug Juvisync (Fierce)
  • FDA grants two orphan drug designations for Bayer's Riociguat (PBR)
  • Actos jury says Takeda failed at safety warnings, but judge tosses $1.7M verdict (Fierce)
  • Durata seeks to GAIN dalbavancin approval (BioCentury)
  • Nektar's NKTR-181 misses in Phase II pain trial (BioCentury) (SCRIP-$) (Fierce) (Reuters)
  • AMAG falls on Deficiencies in Feraheme sNDA (BioCentury)
  • Novo Nordisk's diabetes combination IDegLira impresses in study (PMLive)
  • Dr Reddy's Laboratories infringed on Sunovion's 'Lunesta' drug: US court (India Times)

US: Pharmaceuticals and Biotechnology: General

  • Innovations Expand Types of Seasonal Flu Vaccines (FDA)
  • BARDA seeks Amgen's Neupogen, Sanofi's Leukine for nuke attack countermeasures (SCRIP-$)
  • Ohio Exhausts Supply of Pentobarbital with Murderer's Execution (PharmaManufacturing)

US: Medical Devices

  • Baxter axes jobs after FDA warns over pump (Fierce)
  • TAVR Registry Data Triggers Expansion Of FDA-Approved Indication (Gray Sheet-$)
  • Mobile Medical Applications: A Thoughtful Guidance Is Finalized (FDA Law Blog)
  • Deaths Linked to Cardiac Stents Rise as Overuse Seen (Bloomberg)
  • Jacob Reider named Acting National Coordinator for ONC; temporary replacement for Mostashari (Fierce)
  • Pulse of the industry: medical technology report 2013 (EY)
  • Opportunities, risks seen with dermatology apps (Reuters)
  • Intuitive Surgical's Firefly Fluorescence Imaging Vision System FDA Cleared for Gallbladder Surgery (MedGadget)
  • Beckman Coulter Receives FDA Clearance of AccuTnI+3 Troponin I Assay on UniCel DxI Immunoassay Systems (Press)

US: Assorted And Government

  • Legislation introduced to continue PEPFAR (Reuters)
  • 5 days before shutdown, no deal in sight (Federal Times)
  • CMS May Expand Opioid Abuse Measures To Other Classes In Part D, Insurers Told (Pink Sheet-$)
  • How To Respond When FDA Knocks (Law 360-$)
  • Maker of dangerous pain pills is 'ghost' that can't be found (USA Today)
  • Carney: Obama 'absolutely' rejects CR deal repealing medical device tax (The Hill)
  • Baucus on the medtech tax: 'A deal's a deal' (Mass Device)
  • Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections (DHHS)
  • Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee (DHHS)
  • Senate sends helium bill to the White House (The Hill)
  • NIH expands nationwide network of Vaccine and Treatment Evaluation Units (NIH)
  • U.S. Drug Makers, Others Urge Diplomatic Pressure On India Patent Policy (PharmAsia-$)

Europe

  • ENVI committee voted through entirely different reprocessing rules yesterday (SCRIP-$)
  • Committee for Advanced Therapies issues first recommendation for certification of non-clinical data for an advanced therapy (EMA)
  • EMA to Hold Meeting on Incentivizing Development of New Antibiotics (EMA) (EMA)
  • UK MHRA mulls new incident reporting system (In-Pharma)
  • JA1 Final Technical Report available (EUnetHTA)
  • European regulatory vote skates close to PMA system (EP Vantage)
  • EU IVDs industry needs more than three years for IVDR transition (Clinica-$)
  • EMA Accepts MAA for AstraZeneca's Naloxegol (AZ)

Asia

  • Japan to raid local arm of Novartis over alleged data fabrication: Reports (India Times)
  • Novartis issues apology to Japan after drug trial allegations (Reuters)
  • Prof Ranjit Roy panel recommends upgrading of CDSCO for functional autonomy (PharmaBiz)
  • Registration Open for the 18th AHWP Annual Meeting and the 1st AHWP-RAPS Joint Conference on 2-5 Dec 2013, Malaysia (AHWP)
  • Takeda vaccine division seeks approval of second product, for Hib (SCRIP-$)

Other International

  • A Penicillin Shortage Hinders Treatment For Rheumatic Fever (NPR)

General Regulatory And Interesting Articles

  • 3D printing technology will be an intellectual property nightmare (Inside Counsel)

Regulatory Reconnaissance #165 - 27 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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