Regulatory Focus™ > News Articles > Regulatory Reconnaissance (3 December 2013)

Regulatory Reconnaissance (3 December 2013)

Posted 03 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.

In Focus: US

In Focus: International

  • Analysis: Biosimilar Drugs slow to take off in Europe (Reuters)
  • EU GMP revision comments focus on cross-contamination (Pharmafile)
  • Divergent Standard Care Makes Full EU Regulator/HTA Harmony Unlikely (Pink Sheet-$)
  • AHWP Releases Final Documents for Proposed Adoption (AHWP) (AHWP) (AHWP) (AHWP)
  • India: Medical device companies urge government not to punish all for a quality lapse (India Times)
  • India: Central Drug Authority Bill Delayed (PharmaBiz)
  • Summary of ICH's November 2013 Meeting (ICH)

US: Pharmaceuticals/Biotechnology

  • Extensive Profile of Merck's Suvorexant and its Development and Regulatory Hurdles (New Yorker)
  • Idenix Seeks To Block Launch Of Gilead's HCV Drug Sofosbuvir (Pink Sheet-$) (Press) (SCRIP-$)
  • New FDA MAPP: Good Review Practice: Clinical Review of Investigational New Drug Applications (FDA)
  • FDA Again Blasts Pfizer Unit Over Quality-Control Mishaps (Law 360-$)
  • Voluntary process leaves FDA in the dark over compounders' identities (SCRIP-$)
  • Use Registered Compounders, FDA Says (PharmExec) (Law 360-$) (MedPage Today) (Reuters)
  • Baxter re-files HyQvia for immunodeficiency in US (PMLive) (BioCentury) (Pharma Letter-$) (Press)
  • Gay men push to end 30-year blood donation ban (Washington Times)
  • FDA gives second orphan drug designation to Teva's Treanda (DSN)
  • Actelion's Opsumit disappoints for finger, toe ulcers (Pharma Times)
  • FDA Looking To Patient Advocates To Answer Benefit-Risk Questions (RPM Report-$)
  • FDA is Petitioned Twice More to Delay Start of Hatch-Waxman Exclusivity (FDA Law Blog)
  • Sanofi's Lantus successor on track (PMLive) (Pharma Letter-$) (Fierce) (Reuters)
  • J&J, Medivir's Olysio tested in all-oral HCV trial with Idenix drug (SCRIP-$)
  • FDA pushes review date for Biogen blood drug (MM&M) (Pharma Times) (PMLive) (BioCentury) (Pharma Letter-$) (Reuters)
  • Case Against Wyeth, Similar to Pliva v. Mensing, Upheld on Appeal (CA Court)
  • Phase IV Data Boosts Boehringer's Linagliptin (Press)

US: Medical Devices

  • The Risks of Off-Label Medical Device Use (Star Tribune)
  • Industry Groups, Lawmakers Push Changes To Blackburn HIT Bill (IHP-$)
  • Genetic test maker 23andMe stops marketing after FDA warning (Reuters) (WSJ-$)
  • 23andMe Hit With False Ad Suit Over DNA Tests (Law 360-$) (Forbes)
  • 3 things mHealth startups need to know now about regs (GovHealthIT)
  • FDA clears mobile-enabled Sense4Baby maternal, fetal monitor (MobiHealth News) (Press)
  • TomTec Receives FDA 510(k) Clearance for Its New TomTec-Arena Software (Press)
  • NEC Display Solutions Receives FDA 510(k) Clearance on MD242C2 Medical Diagnostic Monitor (Press)
  • Fujifilm Announces 510(k) Clearance of Detectors for Pediatric Use (Press)

US: Dietary Supplements

  • Regulatory Concerns when Sourcing Ingredients from China (NPI)

US: Assorted And Government

  • Obama pledges $5bn to AIDS fund, directs $100m to NIH for cure (SCRIP-$) (NIH) (AP)
  • Opinion: Don't ban compensation for bone marrow donors (AEI) (AEI)
  • As Hospital Prices Soar, a Single Stitch Tops $500 (NYTimes)

Upcoming Meetings And Events

  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • 11 December 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 11-12 December 2013: Allergenic Products Advisory Committee Meeting (FDA)
  • 12 December 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Analysis: Biosimilar Drugs slow to take off in Europe (Reuters)
  • EU GMP revision comments focus on cross-contamination (Pharmafile)
  • Divergent Standard Care Makes Full EU Regulator/HTA Harmony Unlikely (Pink Sheet-$)
  • Unannounced notified body visits for combination products: tips on how to prepare (Clinica-$)
  • Echo Therapeutics touts positive results for Symphony's CE Mark trial (Mass Device)
  • Concept paper on the second revision of the guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products (EMA)
  • Reflection paper on the use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products (EMA)
  • IQWiG says Xtandi has additional benefit for prostate cancer (BioCentury)
  • UK drug shortages harming patients in 75% of cases (Pharma Times)

Asia

  • AHWP Releases Final Documents for Proposed Adoption (AHWP) (AHWP) (AHWP) (AHWP)
  • India: Medical device companies urge government not to punish all for a quality lapse (India Times)
  • India Looks To Tighten Rules For Filing Pharma Patents (Pharmalot)
  • India: Central Drug Authority Bill Delayed (PharmaBiz)
  • Indian Health ministry to create research unit to provide info on removal of hazardous & irrational drugs from market (PharmaBiz)
  • MHLW Warns Of Side Effects For 13 Drugs (PharmAsia-$)
  • Clinical Trial Data Discussed At Japan-CFDA Meeting (PharmAsia-$)

Other International

  • Summary of ICH's November 2013 Meeting (ICH)

General Regulatory And Interesting Articles

  • New Nanoparticle Can Be Delivered Orally (DD&D)

Regulatory Reconnaissance #213 - 3 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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