Regulatory Focus™ > News Articles > Regulatory Reconnaissance (25 September 2013)

Regulatory Reconnaissance (25 September 2013)

Posted 25 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.

Note: Your news editor is at the AdvaMed 2013 conference through Wednesday, 26 September 2013. Regular news coverage will resume on Thursday.

In Focus: US

  • U.S. Government Shutdown Could Postpone FDA Advisory Panels (The Street) (Fierce) (Eye on FDA) (BioCentury)
  • Medical-Device Makers See EU Rules Slowing U.S. Approvals (Bloomberg)
  • Agila slammed with US FDA warning: 'Visible holes' in gloves (In-Pharma) (Forbes) (Fierce)
  • Pressure Mounts On Drug Security Bill As Stakeholders Await Bicameral Agreement (IHP-$)
  • Pharma squares off against compounders in lobbying fight (Fierce) (Politico)
  • Weight loss: FDA asks for more info on EnteroMedics' Maestro implant (Mass Device) (Fierce)
  • Cigna chief medical officer says 'gap of hopefulness' separates FDA approval & reimbursement (MedCity News)

In Focus: International

  • European Commission Adopts Two Rules Strengthening Standards for Notified Bodies and Surveillance Requirements (EC) (EC) (EC) (Clinica-$) (EurLex) (EurLex)
  • Will ENVI committee vote through entirely different reprocessing rules today? (Clinica)-($)
  • At AdvaMed, European regulations are on many CEOs' minds (Fierce)
  • MHRA seeks to simplify reporting systems (RPS) (MHRA)
  • China FDA Consults Public On Draft Administrative Penalty Procedure Rules (PharmAsia-$)
  • Indian Panel rejects plea for separate compensation for death trials in academic & research centres (PharmaBiz)

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

US: Pharmaceuticals/Biotechnology

  • Agila slammed with US FDA warning: 'Visible holes' in gloves (In-Pharma) (Forbes) (Fierce)
  • FDA's Director of Indian Operations Speaks out, Compares Job to "Climbing Mt. Everest" (FDA)
  • Pressure Mounts On Drug Security Bill As Stakeholders Await Bicameral Agreement (IHP-$)
  • FDA Teams Prepare for Biological Threats (FDA)
  • Pharma squares off against compounders in lobbying fight (Fierce) (Politico)
  • Poll: Senate Bill 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession (PR)
  • Isis Says Ultra-Orphan Use Promises Speedier Approval For ISIS-APOCIIIRx (Pink Sheet-$)
  • FDA approves new dosage strength for Purdue Pharma's Butrans (DSN) (Purdue)
  • AstraZeneca, BMS add promising dapagliflozin PhIII combo diabetes data (Fierce)
  • FDA Generic Labeling Rule Could Help Pfizer In Reglan Product Liability Suit (Pink Sheet-$)
  • Mensing Doesn't Nix Generic-Fosamax Claims, 3rd Circ. Told (Law 360-$)
  • Forest Sues Mylan, Others To Block Generic Savella (Law 360-$)

US: Medical Devices

  • Medical-Device Makers See EU Rules Slowing U.S. Approvals (Bloomberg)
  • Weight loss: FDA asks for more info on EnteroMedics' Maestro implant (Mass Device) (Fierce)
  • Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China (PLoS)
  • Deloitte: Preparation key to networked device security (Fierce)
  • Insulet slides on report of increased adverse events, customer complaints (Mass Device)
  • Sens. Bennet, Merkley Applaud Implementation of New Safety Provision for Medical Devices (Senate)
  • Solana Surgical Receives FDA Clearance, Launches the FuseFORCE™ SuperElastic Fixation System (Solana)
  • GOP senators push for medical device tax repeal vote (The Hill)

US: Assorted And Government

  • U.S. Government Shutdown Could Postpone FDA Advisory Panels (The Street) (Fierce) (Eye on FDA)
  • FDA, NIH mum on plans for handling a government shutdown (BioCentury)
  • Cigna chief medical officer says 'gap of hopefulness' separates FDA approval & reimbursement (MedCity News)
  • FDA Awards Potentially Huge Contract for Nonclinical Information System (FedBizOpps)
  • FDA permits qualified health claim about whole grains and type 2 diabetes, but is the wording so qualified no one will use it? (NI)
  • Hazy FDA Rules Cloud Medical Food's Future (Law 360-$)
  • Rite-Aid, Wal-Mart Can't Shake Glucosamine False Ad Suit (Law 360-$)
  • Report: Anonymous Linking of Distributed Databases (Mini Sentinel)

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)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • European Commission Adopts Two Rules Strengthening Standards for Notified Bodies and Surveillance Requirements (EC) (EC) (EC) (Clinica-$) (EurLex) (EurLex)
  • Will ENVI committee vote through entirely different reprocessing rules today? (Clinica-$)
  • At AdvaMed, European regulations are on many CEOs' minds (Fierce)
  • MHRA seeks to simplify reporting systems (RPS) (MHRA)
  • EC approves three Takeda diabetes products (BioCentury) (SCRIP-$) (Takeda)
  • Pfizer's Xalkori 'not good value for money', says NICE (PMLive) (SCRIP-$)
  • EU and FDA thumbs-up for J&J's Stelara for PsA (Pharma Times)
  • European Medicines Agency publishes CVs of experts involved in its activities (EMA)
  • Call for expressions of interest to appoint patient and healthcare professional representatives as members of Paediatric Committee (EMA)
  • NICE Recommends Genomic Health's Oncotype DX® Test To Guide Chemotherapy Treatment Decisions For Qualified Early-Stage Invasive Breast Cancer Patients (GH)

Asia

  • China FDA Consults Public On Draft Administrative Penalty Procedure Rules (PharmAsia-$)
  • U.S. FDA India Head Will Push For Preventive Controls In Manufacturing Processes (PharmAsia-$)
  • India: Pharma firms to explain medical rationale for combination drugs (India Times) (PharmAsia-$)
  • Indian Panel rejects plea for separate compensation for death trials in academic & research centres (PharmaBiz)
  • CDSCO may re-examine irregularities in HPV vaccine trial by PATH (PharmaBiz)

Other International

  • How Australia Plans To Implement National Health Policy (PharmAsia-$)

Regulatory Reconnaissance #163 - 25 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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