Regulatory Focus™ > News Articles > Regulatory Recon: US Government Investigating Cybersecurity of Medical Devices (22 October 2014)

Regulatory Recon: US Government Investigating Cybersecurity of Medical Devices (22 October 2014)

Posted 22 October 2014 | By Alexander Gaffney, RAC

Regulatory Recon: US Government Investigating Cybersecurity of Medical Devices (22 October 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • U.S. government probes medical devices for possible cyber flaws (Reuters)
  • FDA Advisory Committee Supports Vertex’s Kalydeco (ivacaftor) for Cystic Fibrosis Patients With an R117H Mutation (Tarius) (Pink Sheet-$) (SCRIP-$) (BioCentury) (Reuters) (Press)
  • San Fransisco Now Considering Drug Takeback Program to be Funded by Pharmaceutical Companies (SFGate)
  • FDA Urges Early Communication of CMC Data Gaps for Breakthrough Therapies (Gold Sheet-$)
  • FDA backs further study of kidney biomarkers (BioCentury)
  • Recalled dietary supplements found to still contain banned substances (MNT) (NPI) (NPR) (NYTimes) (Reuters) (NutraIngredients) (JAMA)

In Focus: International

  • Parliament elects new European Commission (EP)
  • Devices/drugs to remain under DG Sanco in newly approved EU Commission (Clinica-$)
  • Biotherapeutics need general chapters not individual Ph. Eur. monographs says EGA (In-Pharma)
  • NICE fast-tracks final 'yes' for GSK skin cancer drug Tafinlar (PharmaTimes) (BioCentury) (SCRIP-$)
  • Testing for Ebola Vaccines to Start Soon, W.H.O. Says (NYTimes) (SCRIP-$) (AP)
  • J&J announces ‘major commitment’ to Ebola effort (Pharmafile)
  • Drugmakers to join forces to make millions of Ebola vaccine doses (Reuters)
  • FDA’s Arista To India: What’s Your Everest? (PharmAsia-$)
  • Expert Panel in India to Consider Changes to Drug Application Forms, Procedures (FDA News-$)

US: Pharmaceuticals and Biotechnology

  • FDA Advisory Committee Supports Vertex’s Kalydeco (ivacaftor) for Cystic Fibrosis Patients With an R117H Mutation (Tarius) (Pink Sheet-$) (SCRIP-$) (BioCentury) (Reuters) (Press)
  • San Fransisco Now Considering Drug Takeback Program to be Funded by Pharmaceutical Companies (SFGate)
  • Abuse-Deterrent Formulations – A Boom or Bust? (Lachman)
  • U.S. Manufacturers Still Favor Three Batches in Process Validation (Gold Sheet-$)
  • FDA Urges Early Communication of CMC Data Gaps for Breakthrough Therapies (Gold Sheet-$)
  • Janssen recalls 13,500 bottles of Xarelto because of contamination (Fierce)
  • Mylan recalls blood pressure med, following recalls of generic by two other drugmakers (Fierce)
  • Packaging Error Prompts Recall of Naproxen Pills (AP) (FDA)
  • Seventh Annual Sentinel Initiative; Public Workshop (FDA)
  • US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations
  • FDA will review Lilly/BI diabetes combo (PharmaTimes) (PharmPro)
  • Alkermes’ New Drug Application for Aripiprazole Lauroxil for Treatment of Schizophrenia Accepted for Filing by U.S. FDA (Press)

US: Pharmaceuticals and Biotechnology: General

  • Officials Say Hepatitis C Drug Too Pricey To Give to All Calif. Inmates (CA Healthline)
  • Giving pricey hepatitis drug to prisoners may be financially wise (Reuters)
  • Synageva BioPharma Starts Rolling Submission Of A Biologics License Application To The FDA For Sebelipase Alfa (Press)
  • Relypsa Submits New Drug Application to U.S. FDA Seeking Approval for Patiromer for Oral Suspension to Treat Hyperkalemia (Press)
  • Oramed's oral insulin succeeds in study, shares jump (Reuters)

US: Medical Devices

  • U.S. government probes medical devices for possible cyber flaws (Reuters)
  • FDA backs further study of kidney biomarkers (BioCentury)
  • Avoid These 5 MDR Pitfalls (Silver Sheet-$)
  • EPA Releases New Rules on Dental Amalgam (EPA)
  • CMO says Covidien wants to engage parallel review process (Fierce)
  • Jury deliberations begin in first trial over DePuy's Pinnacle hips (Reuters)
  • Medical Device Registries: Advancing device innovation and patient safety (Pew)
  • FDA Awards Contract to Study "Wear and Corrosion" of Hip Implants (FDA)
  • FDA Classifies Nucleic Acid-Based Devices for the Detection of Mycobacterium Tuberculosis Complex and the Genetic Mutations Associated With Antibiotic Resistance as Class II Devices (FDA)

US: Dietary Supplements

  • Recalled dietary supplements found to still contain banned substances (MNT) (NPI) (NPR) (NYTimes) (Reuters) (NutraIngredients) (JAMA)
  • ‘Some companies claiming they’re strengthening their defense against chondroitin adulterants are not using the right method’: Synutra President (NutraIngredients)

US: Assorted And Government

  • Mining Social Media for Adverse Events (Policy and Medicine)
  • An organ shortage kills 30 Americans every day. Is it time to pay donors? (AEI)

Upcoming Meetings

Ebola Outbreak

  • Testing for Ebola Vaccines to Start Soon, W.H.O. Says (NYTimes) (SCRIP-$) (AP)
  • J&J announces ‘major commitment’ to Ebola effort (Pharmafile)
  • Drugmakers to join forces to make millions of Ebola vaccine doses (Reuters)
  • FDA Guidelines Restrict Use of Ebola Scanning Device at Hospitals (VICE)
  • U.S. Government Engages Dx Firms For Rapid, Field-Based Ebola Test (Gray Sheet-$)
  • MSF aims to start drug trials in Ebola clinics next month (Reuters)
  • Tekmira starts limited manufacturing of therapeutic for Ebola (Reuters)
  • Ebola crisis draws experimental drugs, along with ethical concerns (ModernHealthcare)
  • An Ebola quarantine (21 days) is nothing compared to the one for drug-resistant TB (2 years) (MedCityNews)

Europe

  • Parliament elects new European Commission (EP)
  • Devices/drugs to remain under DG Sanco in newly approved EU Commission (Clinica-$)
  • Biotherapeutics need general chapters not individual Ph. Eur. monographs says EGA (In-Pharma)
  • NICE fast-tracks final 'yes' for GSK skin cancer drug Tafinlar (PharmaTimes) (BioCentury) (SCRIP-$)
  • NICE under increased pressure over conflicts of interest (Pharmafile) (PharmaTimes)
  • Pressure put on Roche to cut Kadcyla's UK price (PMLive) (SCRIP-$) (Reuters)
  • Ben Goldacre: Pharma industry has destroyed its own reputation (EurActiv)
  • GW Pharma's Epidiolex For Dravet Syndrome Gets EU Orphan Designation (RTT)
  • Sorin Group Announces CE Mark Approval and First Implant of MEMO 3D ReChord (Press)
  • Ferring Pharmaceuticals: Cortiment MMX, a new treatment for ulcerative colitis, receives European approval (Press)

India

  • FDA’s Arista To India: What’s Your Everest? (PharmAsia-$)
  • Expert Panel in India to Consider Changes to Drug Application Forms, Procedures (FDA News-$)
  • Pharmacists demand strengthening of regulatory mechanism to check irrational use of antibiotics (PharmaBiz)

Other International

  • AHWP: Proposed document "Role of Standards in the Assessment of Medical Devices" (AHWP)
  • AHWP: Proposed document "Comparison between the Common Submission Dossier Template (CSDT) format for In Vitro Diagnostic Medical Devices and the GHTF Summary Technical Documentation (STED) formats for In Vitro Diagnostic Medical Devices (AHWP)

Clinical Trials

  • Genomically driven breast cancer trial: Ready to play? (SCRIP-$)

General Regulatory And Interesting Articles

  • Coté Orphan Launches Free Mobile Application That Transforms Information Access To FDA and EMA Orphan Drug Status (Press)
  • Supercomputers Link Proteins to Drug Side Effects (DD&D)
  • Deadly spider found in UK shopping could provide alternative to Viagra (In-Pharma)
  • How do we treat life-threatening anemia in a Jehovah's Witness patient? (PubMed)

Regulatory Reconnaissance #424 – 22 October 2014

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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