Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Mind-Controlled Prosthetic Obtains FDA Approval (12 May 2014)

Regulatory Reconnaissance: Mind-Controlled Prosthetic Obtains FDA Approval (12 May 2014)

Posted 12 May 2014 | 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

  • Clinical trials transparency: the journey so far (Pharmafile)
  • Is Primodos the Forgotten Thalidomide? (Telegraph)
  • Europe extends clinical trial project with African researchers (PMLive)
  • On Mobile Medical Apps in the EU (MDL)
  • Eli Lilly to appeal $450 million Brazil poisoning fine (Pharma Times) (Law 360-$) (Pharma Letter-$)
  • Health Canada recalls medical marijuana for 2nd time in a month (Toronto Sun)

US: Pharmaceuticals/Biotechnology

  • Congress Dives Into Biomedical Innovation: Will It Drown In A Deep Sea Of Competing Needs? (Pink Sheet-$) (BioCentury)
  • Journal Reprint Guidance: Industry And FDA Still At Odds Over Off-Label Information (Pink Sheet-$) (SCRIP-$) (IHP-$)
  • Boehringer launches new transparency regime (Pharmafile) (Press)
  • FDA's Top Agenda Maker: Commissioner, Congress - Or The Courts? (Pink Sheet-$)
  • "Breakthrough" Review: FDA And Sponsors Discuss Ways To Improve Efficiency (Pink Sheet-$)
  • CHPA Files Comments to FDA Regarding OTC Monograph System (Press)
  • Duchenne Experts Developing Guidance for FDA (PPMD)
  • Pa. considers restricting access to Zohydro (NewsWorks)
  • Think You Have A "Breakthrough" Drug? Think Again, FDA's Woodcock Says (Pink Sheet-$)
  • Merck's Zontivity Label Isn't Weighed Down With Safety Language (Pink Sheet-$)
  • FDA Approves Bayer's Kogenate FS Antihemophilic Factor VIII (recombinant) for Routine Prophylaxis in Adults with Hemophilia A (Press) (PharmPro)
  • Biotech Due Diligence: Deconstructing the Milestone Calendar (Forbes)
  • Actavis Files ANDA for Generic Weight Loss Drug Qsymia (Fierce) (BioCentury) (SCRIP-$)
  • 2014 FDA Drug Approval Calendar (The Street)

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

US: Pharmaceuticals and Biotechnology: General

  • Mergers don't make good medicines (AEI)
  • Medicare Won't Always Pay For Boomers' Pricey Hepatitis C Drugs (NPR)
  • ACA Cost-Sharing Could Limit Rx Access: PhRMA (MedPage Today)
  • Texas biomanufacturing centre aims to up US medical countermeasures (BioPharma Reporter)

US: Medical Devices

  • Mind-controlled prosthetic arm from Segway inventor gets FDA approval (Verge) (Gray Sheet-$) (MDDI) (Mass Device) (MedPage Today) (FDA) (Reuters) (Bloomberg)
  • Cybersecurity at HRS2014: Are medical devices safe? (Mass Device)
  • Feds probe Masimo over Pronto, Pronto-7 devices (Mass Device) (Fierce)
  • Are You Ready for UDI? 6 Questions to Ask Yourself (Medical Design)
  • Where Did Medtech Innovation Come from in 2013? (MDDI)
  • FDA Wants Report on Market Share of Medical Devices (FDA)
  • Halt Medical Announces FDA Clearance of the Acessa Guidance Hand Piece for Treatment of Symptomatic Uterine Fibroids (Press)
  • Routine Shock Testing Not Required During ICD Implantation (Forbes)
  • Sorin Group Announces Freedom Solo FDA Study Results (Press)
  • Universal Mammograms Show We Don't Understand Risk (NYTimes)
  • Esaote Receives FDA Clearance for Virtual Navigator Ultrasound Fusion Imaging (Press)
  • US: Dietary Supplements
  • Race to Market: Drugs vs. Dietary Supplements; FDA Plants a Landmine (FDA Law Blog)

US: Assorted And Government

Europe

  • Clinical trials transparency: the journey so far (Pharmafile)
  • Is Primodos the Forgotten Thalidomide? (Telegraph)
  • Europe extends clinical trial project with African researchers (PMLive)
  • Public consultation of the Draft Project Plan on "Biodegradable stents for benign refractory esophageal stenosis" (EUnetHTA)
  • On Mobile Medical Apps in the EU (MDL)
  • CMDh clarifies numbering of eCTD sequences for MRP/DCP lifecycle (Exalon)
  • UK Legislator Calls on MHRA to Reclassify Vaginal Mesh Products (The Courier)
  • Breach of national and EU legislation on drug prices by Greece claimed by pharma trade group (Pharma Letter-$)
  • The Italian drug agency (AIFA) has approved the refund of Zebinix  (eslicarbazepine acetate) as adjunctive treatment once daily for the treatment of partial epilepsy in adults (Press)

India

  • Commerce ministry not to press on implementation of barcoding for primary packaging (PharmaBiz)

Other International

  • Eli Lilly to appeal $450 million Brazil poisoning fine (Pharma Times) (Law 360-$) (Pharma Letter-$)
  • Biogen, Sobi pledge hemophilia drug donation in developing world (Reuters)
  • Health Canada recalls medical marijuana for 2nd time in a month (Toronto Sun)

General Regulatory And Interesting Articles

  • Big pharma should clean up act or face reputational apocalypse (Business Day)

Regulatory Reconnaissance #316 - 12 May 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.

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.

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


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