Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Gets a Snow Day (13 February 2014)

Regulatory Reconnaissance: FDA Gets a Snow Day (13 February 2014)

Posted 13 February 2014 | By Alexander Gaffney, RAC

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In Focus: US

In Focus: International

  • Japan To Give Regenerative-Medicine Products 25-Year Patent Protection (PharmAsia-$)
  • French cancer plan welcomed by industry and regulators (SCRIP-$)
  • Is it a device, or isn't it? MHRA provides some down-to-earth guidance (Clinica-$)
  • Pfizer faces legal action from Australian competition regulator (Reuters) (WSJ-$) (Bloomberg)

US: Pharmaceuticals/Biotechnology

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

US: Pharmaceuticals and Biotechnology: General

  • Changes proposed to US CFATS facility security rules (In-Pharma)
  • Oklahoma Pharmacy Sued Over Lethal Injection Drug (AP)
  • Dem bill lets drug czar study effects of making pot legal (The Hill)
  • DEA Needs Warrants To Get Drug Records, Judge Says (Law 360-$) 

US: Medical Devices

  • New alliance aims to advance telehealth regulatory efforts (Fierce)
  • 8 types of medical apps a Senate bill asks FDA to stop regulating (MobiHealthNews)
  • FDA Questions Missing Data, Sizing Method For Visian Astigmatism-Correcting Intraocular Lens (Gray Sheet-$)
  • The Dog Ate My Medical Device: Designing Devices for the Real World (MDDI)
  • EnteroMedics lands a date with the FDA (Mass Device)
  • CamNtech Receives FDA Clearance for Wrist-Worn Motion Tracker and Diary (MedGadget)
  • HeartSine warned by FDA for medtech reporting, tracking violations (Mass Device)
  • InControl Medical Gains FDA Clearance for InTone MV Device (Press)
  • Teleflex Medical Announces Worldwide Voluntary Recall of ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) (Press)

US: Assorted And Government

  • FDA Closed Today due to Winter Storm (The Hill)
  • Building a Case, AdComm Preparation, Part 2 (Eye on FDA)
  • Health Care Self-Disclosure Protocols -- Is It Worth It To Self-Report? (Forbes)
  • Physician Payment Sunshine Act: Will Sunshine Data Help Qui Tam Whistleblowers and Their Attorneys? (Policy and Medicine)

Upcoming Meetings And Events

  • 12 February 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 13 February 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 14 February 2014: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • French cancer plan welcomed by industry and regulators (SCRIP-$)
  • Is it a device, or isn't it? MHRA provides some down-to-earth guidance (Clinica-$)
  • Call for Expression of Interest to Participate in early dialogue between HTA bodies and healthcare product developers (Inside Medical Devices)
  • NICE says stop prescribing drugs to prevent schizophrenia (OnMedica)
  • Cancer drug maker wants 4000% Spanish price hike (The Local)
  • Full Speed Ahead for EU Data Protection Reform (GRE Law Blog)
  • "Green light" for Bayer's new transparent low dose contraceptive patch (Press)
  • Calcivis Caries Activity Imaging System Receives CE Mark (MedGadget)

India

  • India To Provide Last-Chance HIV/AIDS Drugs For Free, Extend Access (PharmAsia-$)

Japan & China

  • Japan To Give Regenerative-Medicine Products 25-Year Patent Protection (PharmAsia-$)

Other International

  • Pfizer faces legal action from Australian competition regulator (Reuters) (WSJ-$) (Bloomberg)
  • Australian regulatory guidelines for biologicals (ARGB) (TGA)
  • Australia Marks 50 Years of ADEC Committee (TGA)

General Regulatory And Interesting Articles

  • P values, the 'gold standard' of statistical validity, are not as reliable as many scientists assume. (Natue)
  • HIV/AIDS firms top new pharma reputation list (Pharma Times)
  • Open Communication Helps Reduce Rare Disease Drug Development Risk (BIO)
  • Popular disinfectants do not kill HPV (Press)
  • Vaccines reduce risk of strokes in children (USA Today)

Regulatory Reconnaissance #256 - 13 February 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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