Regulatory Focus™ > News Articles > Regulatory Recon: Warning Letters to Device Companies on the Decline (7 October 2014)

Regulatory Recon: Warning Letters to Device Companies on the Decline (7 October 2014)

Posted 07 October 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Warning Letters to Device Companies on the Decline (7 October 2014)

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

In Focus: US

  • FDA Device Warning Letters Decline For First Time In Five Years (MedDeviceOnline)
  • FDA calls for new opioids standard (BioCentury) (Pharmalot) (JAMA) (FDA)
  • BrainStorm gets FDA fast-track status for ALS stem cell therapy (Reuters) (Press)
  • How Will 3rd FDA Panel View Boston Scientific's Watchman Heart Device? (MDDI) (Mass Device)
  • Medical Company May Be Falling Short Of Its Patient Safety Ideals (ProPublica)
  • Hi-Tech Execs To Remain Jailed Until Recall Is Complete (Law 360-$)
  • Bayer Fights Back Against FTC in Probiotic Litigation (NPI) (Law 360-$)
  • Dallas Ebola victim treated with experimental drug (CNBC) (Xconomy) (SCRIP-$)

In Focus: International

  • Sovaldi may be cost-effective, but the U.K. can't afford it, documents say (Fierce) (Pharmafile)
  • EMA's Walks Fine Line On How It Will Publish Clinical Study Reports (Pink Sheet-$)
  • Dawn of the Qualified Person: how medtech should prepare for new EU regulatory role (Clinica-$)
  • EDQM set to fight fakes and forge closer ties with EMA (In-Pharma)
  • Sovaldi Deal: Gilead Armored From GMP Issues Of Indian Firms (PharmAsia-$)
  • CDSCO to start collection of drug samples in 15 categories for spurious drugs survey (PharmaBiz)

US: Pharmaceuticals and Biotechnology

  • FDA calls for new opioids standard (BioCentury) (Pharmalot) (JAMA) (FDA)
  • EYLEA (aflibercept) Injection Receives FDA Approval for Macular Edema Following Retinal Vein Occlusion (Press) (BioCentury)
  • Black-box warnings easily are overlooked (Gazette)
  • Alabama federal judge: Time to end nationwide litigation against Pfizer anti-smoking drug Chantix (Birmingham)
  • Sagent recalls NSAID made by Cadila over expiry issue (Fierce) (FDA)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • BrainStorm gets FDA fast-track status for ALS stem cell therapy (Reuters) (Press)
  • Acacia Pharma Announces Positive Phase 3 Results For APD421 in Post-Operative Nausea & Vomiting (PONV) (Press)

US: Pharmaceuticals and Biotechnology: General

  • ​Specialty Drugs Offer “Reasonable” Value, Tufts Analysis Finds (Pink Sheet-$) (CEA) (Health Affairs) (WonkBlog)
  • Sanofi Notifies U.S. About Overseas Bribery Allegations (Bloomberg) (WSJ-$) (Law 360-$)
  • 3 east Texas residents indicted in prescription drug smuggling ring (ICE)
  • RICO Challenges to Drug Co-Pay Programs Fall Like Dominoes: Another Federal Court Judge Dismisses RICO Claim (FDA Law Blog)

US: Medical Devices

  • How Will 3rd FDA Panel View Boston Scientific's Watchman Heart Device? (MDDI) (Mass Device)
  • Medical Company May Be Falling Short Of Its Patient Safety Ideals (ProPublica)
  • FDA Warning Letters Decline For First Time In Five Years (MedDeviceOnline)
  • Professor Kevin Fu Answers Your Questions About Medical Device Security (Slashdot)
  • The Placebo Effect Doesn’t Apply Just to Pills (Upshot)
  • Philips secures 510(k) clearance to market the first clinical applications for its new digital health platform (Press)
  • September 2014 510(k) Clearances (FDA)

US: Dietary Supplements

  • Hi-Tech Execs To Remain Jailed Until Recall Is Complete (Law 360-$)
  • Bayer Fights Back Against FTC in Probiotic Litigation (NPI) (Law 360-$)
  • “Wrong Type Of Expert” Advised FTC On Phillip’s Colon Health Claims – CRN (Tan Sheet-$)
  • FDA Authorizes New York Supplement Manufacturer to Resume Operations (NPI)
  • 'Jacked Power' pre-workout supplement under investigation following woman’s brain haemorrhage (Food Quality)

US: Assorted And Government

  • $1.1 Billion in Drug, Device Payments to Doctors Not Included in New Federal Database (ProPublica)

Upcoming Meetings

Ebola Outbreak

  • Ethical choices surround a potential Ebola vaccine (WaPo)
  • Dallas Ebola victim treated with experimental drug (CNBC) (Xconomy) (SCRIP-$)
  • Ebola Protective Suits Are In Short Supply (NPR)
  • Rapid Ebola Detector Identifies Infected Patients in About an Hour (MedGadget)

Europe

  • Sovaldi may be cost-effective, but the U.K. can't afford it, documents say (Fierce) (Pharmafile)
  • EMA's Walks Fine Line On How It Will Publish Clinical Study Reports (Pink Sheet-$)
  • EMA Management Board: highlights of October 2014 meeting (EMA)
  • New EMA trial transparency policy may mean higher legal costs for CROs say campaigners (In-Pharma)
  • Dawn of the Qualified Person: how medtech should prepare for new EU regulatory role (Clinica-$)
  • EDQM set to fight fakes and forge closer ties with EMA (In-Pharma)
  • European doctors want more drug info (PharmaTimes)
  • Galderma earns wrath of PMCPA in unprecedented case (Pharmafile)
  • Cancer Drug Fund moves towards a price assessment role (PMLive)
  • Wrong move, wrong time? Former health minister to head DG Sanco just as it loses device/drug remit (Clinica-$)

India

  • Sovaldi Deal: Gilead Armored From GMP Issues Of Indian Firms (PharmAsia-$)
  • CDSCO to start collection of drug samples in 15 categories for spurious drugs survey (PharmaBiz)
  • Experts demand removal of health secretary for failing to address severe shortage of HIV-AIDS drugs (PharmaBiz)
  • Indo-US IP working group: good, bad or status quo? (SCRIP-$)

Canada

  • Calls growing louder for national prescription drug plan (CTV)
  • Canadian Authorities Warn About Elevated Risk of Cardiovascular Risks, Stroke from Diclofenac (Health Canada)

Australia

  • Australian Authorities Warn About Elevated Risk of Cardiovascular Risks, Stroke from Diclofenac and NSAIDS (Health Canada) (TGA) (TGA)

General Regulatory And Interesting Articles

  • #2014RAPS Recap: What’s Simplexity and Why You Should Embrace It (MedScrum)
  • Drugs Cause Most Fatal Allergic Reactions, Study Finds (NYTimes)
  • Gene therapy: a treatment coming of age (PharmJournal)
  • Viagra could damage vision in people with an inherited eye disease (PharmJournal)

Regulatory Reconnaissance #415 – 7 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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