Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Court Finds State Painkiller Ban Unconstitutional (16 April 2014)

Regulatory Reconnaissance: Court Finds State Painkiller Ban Unconstitutional (16 April 2014)

Posted 16 April 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

  • Russia Panel Recommends Lifting Ban On Medical Advertising (PharmAsia-$)
  • EMA and EU national competent authorities agree on action plan to address medication errors (EMA)
  • New EU Surveillance Measures for Flu Vaccines Come into Effect (EMA)
  • Pfizer cold on Viagra-laced ice cream idea in UK (In-Pharma)

US: Pharmaceuticals/Biotechnology

  • U.S. court reverses Massachusetts ban on Zogenix pain drug (Reuters) (WaPo) (The Hill) (Law 360-$) (BioCentury) (SCRIP-$) (Pink Sheet-$) (AP) (Zogenix)
  • FDA approves GSK's Tanzeum to treat type 2 diabetes (FDA)(Fierce) (Pharma Times) (AP) (WSJ-$) (SCRIP-$) (BioCentury) (Reuters) (GSK) (PMLive)
  • Boehringer plans to open trial data back to 1998 (PMLive)
  • GDUFA and the API Industry - One Year Later (Cortelis)
  • FDA Calls For More Regenerative Therapy Standards-Setting Collaboration (IHP-$)
  • Impax believes manufacturing issues are fixed (Fierce)
  • Sen. Floats Bill to Combat Antibiotic-Resistant Microbes (Law 360-$)
  • FDA Reschedules Workshop on Communicating Uncertainty (FDA)
  • FDA Workshop: Advancing the Development of Pediatric Therapeutics: Pediatric Bone Health (FDA)
  • Arizona Senate Clears Bill to Grant Compassionate Use Access to Terminal Patients (AZStar)
  • FDA extends market exclusivity of BioMarin's Phenylketonuria drug Kuvan for six months (PBR)

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

  • Baxter Meets Primary Efficacy Endpoint in Phase 3 Trial of BAX 111, Investigational Stand-Alone Recombinant Treatment for von Willebrand Disease (Press)
  • J&J Building Case For Co-Administration Of Olysio With Gilead's Sovaldi (Pink Sheet-$)

US: Pharmaceuticals and Biotechnology: General

  • Ranbaxy's Regulatory Problems Cost Consumers $900 Million (Fierce)
  • Google faces new pressure from states to crack down on illegal online drug sales (WaPo)
  • Chimeric mouse study 'could have prevented human deaths in 1993 drug trial' (MNT)

US: Medical Devices

  • FDA OKs new generation Boston Scientific heart pacing devices (Reuters) (Press) (Mass Device)
  • Medtronic Prevented From Selling Heart Valve In U.S. (WSJ-$) (Modern Healthcare) (Forbes)
  • FDA Seeks Comment on Proposed Health IT Strategy That Aims to Promote Innovation (FDA)
  • Can an OSHA NRTL Certify to ANSI/AAMI ES60601-1:2005/(R)2012 with Amendments Yet? (Eisner Safety)
  • When Spine Implants Cause Paralysis, Who Is to Blame? (WSJ-$)
  • Medical devices for kids are often only tested on adults (Reuters) (Study)
  • DNA Alternative to Pap Smear Sparks Medical Debate (AP)
  • Despite the Risks, and Because of Them, the FDA Should Permit Recycling Medical Implants (Hastings)
  • Collagen Matrix, Inc. Receives FDA 510(k) Clearance of a Flexible Collagen Nerve Conduit for Reduction of Painful Neuroma Formation (Press)

US: Dietary Supplements

  • FDA warns maker of controversial sports supplement Craze (USA Today) (FDA) (NPI)
  • Most supplements probably don't work, but Americans still love them (Today)
  • Star Scientific, FDA Dispute Reflects NDI Uncertainty (NPI)

US: Assorted And Government

  • Scientists embark on unprecedented effort to connect millions of patient medical records (WaPo)
  • H.R.4451 -- Dangerous Products Warning Act (House)

Europe

  • EMA and EU national competent authorities agree on action plan to address medication errors (EMA)
  • New EU Surveillance Measures for Flu Vaccines Come into Effect (EMA)
  • NICE recommends ESAs for cancer treatment anemia (BioCentury)
  • IQWiG rebuffs Novo's NovoEight (BioCentury)

Japan & China

  • China Scraps Drug Price-Control System For More-Moderate Alternative (PharmAsia-$)

Other International

  • Russia Panel Recommends Lifting Ban On Medical Advertising (PharmAsia-$)
  • Health Canada updates medical device license application forms (Mass Device)

General Regulatory And Interesting Articles

  • Pfizer cold on Viagra-laced ice cream idea in UK (In-Pharma)
  • Risks Of Popular Anxiety Drugs Often Overshadowed (NPR) (NPR)

Regulatory Reconnaissance #299 - 16 April 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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