Regulatory Focus™ > News Articles > Regulatory Recon: Why Did Amazon Meet With FDA? (22 August 2014)

Regulatory Recon: Why Did Amazon Meet With FDA? (22 August 2014)

Posted 22 August 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Why Did Amazon Meet With FDA? (22 August 2014)

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

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In Focus: US

In Focus: International

  • EMA to review Basilea's Antifungal Drug isavuconazole (BioCentury) (SCRIP-$)
  • Cubist Announces EMA Acceptance of Ceftolozane/Tazobactam Marketing Authorization Application for Review (Press) (Fierce)
  • Study Comparing Canada and Europe Says Faster Drug Approvals Will Not Increase Safety Risks: Canadian Health Policy Institute (Press)
  • Australia to boost clinical trial landscape (BioSpectrum)
  • US: Pharmaceuticals and Biotechnology
  • FDA approves BMS/Pfizer’s Eliquis in DVT and PE (Pharmafile) (SCRIP-$) (Forbes) (BioCentury) (Reuters) (Press) (Updated REMS)
  • Amazon meets with FDA, healthcare is likely the topic (Modern Healthcare)
  • Another drug company blames freezing during delivery for product problems (Fierce) (The Street)
  • FDA Releases Updated Opioid REMS (FDA)
  • Ranbaxy to be hit with Major Fine: Report (India Times)
  • Opioid Upscheduling, the Precautionary Principle, and the Law of Unintended Consequences (DrugWonks)
  • Do Dying Patients Have a Right to Try Experimental Drugs? Libertarians Say Yes (Bloomberg)
  • FDA Clears Way for Fusilev, Sular Generics (FDA) (FDA)
  • Systems pharmacology modeling: an approach to improving drug safety (PubMed)
  • FDA Sends Warning Letter to Animal Drug Compounding Firm (The Horse)

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

US: Pharmaceuticals and Biotechnology: General

  • USP Joins Fight Against Illegal Online Drug Sales (Press)

US: Medical Devices

  • FDA medtech approval slowdown hits surgical devices hardest (EP Vantage)
  • FDA clarifies UDI requirements with new guidance (Fierce) (FDA)
  • Proposed FDA Definition Of Custom Devices Will Limit Access, Congressman Says (Gray Sheet-$)
  • 'We Are Going For Change': A Conversation With 23andMe CEO Anne Wojcicki (Forbes)
  • FDA OKs return of Covidien's Recalled Pipeline embolism device (Mass Device) (Fierce)
  • Intuitive Surgical wins FDA OK for Firefly imaging (Mass Device)
  • Revamping Microbiological Test Methods for Contact Lenses Products; Public Workshop (FDA)
  • Joint Commission issues Sentinel alert on medical tubes (Modern Healthcare)

US: Dietary Supplements

  • AHPA's data shows FDA ramping up enforcement on tainted weight loss, sex products (NI-USA)
  • On Working with FDA (NPI)
  • Russia removes dietary supplements from import ban list (NI-USA)

US: Assorted And Government

  • Whole Foods Slapped With $5M Homeopathy Class Action (Law 360-$)
  • The Ice Bucket Challenge Has Raised More Than $13 Million -- Meanwhile, Medical Research Has Been Cut By Billions (HuffPo)

Ebola Outbreak

  • Miracle, ZMapp or a strapping immune system? (SCRIP-$) (NYTimes) (CDC)
  • WHO says drawing up six-nine month strategy to combat Ebola (Reuters)
  • Would A Prize Help Speed Development Of Ebola Treatments? (NPR)
  • China To Require Preapproval Of All Ebola Treatments (PharmAsia-$)
  • WHO says 70 die from illness in Congo, denies Ebola link (Reuters)

Europe

  • EMA to review Basilea's Antifungal Drug isavuconazole (BioCentury) (SCRIP-$)
  • Cubist Announces EMA Acceptance of Ceftolozane/Tazobactam Marketing Authorization Application for Review (Press) (Fierce)
  • European Public Health Alliance urges European Commission to support new drugs to market (Pharma Letter-$)
  • Direct Flow wins CE Marks for TAVI device (Mass Device)
  • European Medicines Agency closed 25 August 2014 (EMA)

India

  • Marck Biosciences plans to re-apply for FDA certification within next one yr (Business Standard)

Canada

  • Study Comparing Canada and Europe Says Faster Drug Approvals Will Not Increase Safety Risks: Canadian Health Policy Institute (Press)

Australia

  • Australia to boost clinical trial landscape (BioSpectrum)
  • TGA Opens Consultation Period of Medicines Labeling Proposals (TGA)

Regulatory Reconnaissance #384 – 22 August 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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