Regulatory Focus™ > News Articles > Regulatory Reconnaissance: UK Lawmakers Demand Drug Data (3 January 2013)

Regulatory Reconnaissance: UK Lawmakers Demand Drug Data (3 January 2013)

Posted 03 January 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

  • FDA Closes 2013 With Flurry Of Citations For Misleading Rx Promotions (Pink Sheet-$)
  • Budget Deal Portends Well For FDA In FY 2014, Funding Advocates Say (IHP-$)
  • Sixth Circuit Affirms Preemption Defense in Suit against Branded and Generic Drug Companies (WLF)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • FDA Closes 2013 With Flurry Of Citations For Misleading Rx Promotions (Pink Sheet-$)
  • Sixth Circuit Affirms Preemption Defense in Suit against Branded and Generic Drug Companies (WLF)
  • The Federal Circuit Wades into FDC Act Preemption and Intended Use in RevitaLash Decision (FDA Law Blog)
  • Sanofi New Year data resolution may not go far enough (SCRIP-$)
  • The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians (FDA)
  • FDA Regulator Greg Reaman Given Award for Work in Treating Childhood Cancers (FDA)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Samsung gets FDA clearance for S Health app (MobiHealthNews)
  • FDA clears Kinsa's connected oral thermometer (MobiHealthNews)
  • Provant Therapy System FDA Cleared for Patients with Metallic Implants (MedGadget)
  • Electromed Receives FDA Approval for Next Generation SmartVest Airway Clearance System (MedGadget)
  • Nipro Diagnostics, Inc. Initiates Voluntary Recall of Certain TRUEbalance and TRUEtrack Blood Glucose Meters (Press)
  • Dirty endoscopes blamed for superbug outbreak (NBC)

US: Dietary Supplements

  • CFSAN 2014 Goals Include FSMA Enforcement, Targeting Pathogens (The Tan Sheet-$)

US: Assorted And Government

  • Budget Deal Portends Well For FDA In FY 2014, Funding Advocates Say (IHP-$)

Upcoming Meetings And Events

  • 10 January 2013: National Biodefense Science Board Meeting (DHHS)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

Asia

  • China says child deaths not linked to hepatitis vaccine (Reuters) (AP)
  • AHWP: CALL FOR COMMENTS on the PROPOSED document "Guidance on the Quality Management System for Medical Device Distributor" (AHWP)
  • Inavir cleared for flu prevention in Japan (SCRIP-$)

General Regulatory And Interesting Articles

  • Acupuncture, Real or Not, Eases Side Effects of Cancer Drugs (NYTimes)
  • Why Ending Malaria May Be More About Backhoes Than Bed Nets (NPR)

Regulatory Reconnaissance #228 - 3 January 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.


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