Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Records Show Boehringer Hid Pradaxa Records from FDA (26 February 2014)

Regulatory Reconnaissance: Records Show Boehringer Hid Pradaxa Records from FDA (26 February 2014)

Posted 26 February 2014 | By Alexander Gaffney, RAC 

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In Focus: US

  • Boehringer Kept Pradaxa Analysis From FDA, Records Show (Bloomberg)
  • Lawmakers' report: FDA monitoring of staff e-mails may have violated whistleblowing law (Washington Post)
  • Novartis to Open Data on Newly Approved Medicines to Researchers (Bloomberg)
  • F.D.A. Weighs Fertility Method That Raises Ethical Questions (NYTimes) (Washington Post) (CBS) (AP) (Reuters)
  • FDA-approved drug Zohydro faces public backlash (The Hill) (NPR) (Modern Healthcare)
  • FDA Panel Votes Against OTC Asthma Spray Due To Safety Concerns (Tan Sheet-$)
  • FDA Rips Research Co. Over Unapproved Electromagnet Trials (Law 360-$)
  • Will Social Media Kill the Placebo Trial? (Ask CATO)

In Focus: International

  • German bill extending price freeze to 2017 forces companies to reveal discounts (SCRIP-$)
  • Another French breast implant scandal erupts and spreads (Fierce)
  • Staff Changes at Indian Regulator Could Boost Review Processes in the Long Term (Emergo)
  • India moves closer to approving key medical device legislation (Fierce)
  • Indian drug regulator seen as corrupt: Roger Bate (India Times)

US: Pharmaceuticals/Biotechnology

  • Boehringer Kept Pradaxa Analysis From FDA, Records Show (Bloomberg)
  • Lawmakers' report: FDA monitoring of staff e-mails may have violated whistleblowing law (Washington Post)
  • Novartis to Open Data on Newly Approved Medicines to Researchers (Bloomberg)
  • F.D.A. Weighs Fertility Method That Raises Ethical Questions (NYTimes) (Washington Post) (CBS) (AP) (Reuters)
  • FDA-approved drug Zohydro faces public backlash (The Hill) (NPR) (Modern Healthcare)
  • PLAN B Revisited: FDA Rules on One-Step Exclusivity and ANDA Labeling Carve-Outs (FDA Law Blog)
  • FDA approves Anika Therapeutics arthritis drug (Reuters) (Press) (SCRIP-$) (BioCentury)
  • Biosimilars bill passes House, heads to Indiana governor (IBJ) (BIO)
  • Lupin gets USFDA nod for generic version of Mycobutin Capsules (India Times)
  • FDA clears Iroko pain drug Tivorbex for US market (SCRIP-$) (BioCentury)

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

US: Pharmaceuticals and Biotechnology: General

  • Big Pharma's Big Fines (ProPublica)
  • Prescriptions higher for women, long a target of tranquilizer ads (Journal-Sentinel)
  • Painkillers, tranquilizers an increasingly fatal mix (Journal-Sentinel)
  • US-India IPR spat puts spotlight back on 3(d) and TRIPS divide (SCRIP-$)
  • Shire Unit Settles Genzyme False Advertising Suit (Law 360-$)

US: Medical Devices

  • FDA Panel Votes Against OTC Asthma Spray Due To Safety Concerns (Tan Sheet-$)
  • FDA Rips Research Co. Over Unapproved Electromagnet Trials (Law 360-$)
  • Report: U.S. hospitals, medical devices rife with stealthy cybersecurity attacks (Mass Device)
  • FDA Approves New Catheter For Treatment Of Atrial Fibrillation (Forbes)
  • Pessimistic Wright Medical wins FDA date for Augment (Mass Device)
  • FDA recalls guidewires used in cath procedures (Cardiovascular Business) (FDA)
  • Verizon's FDA-cleared patient engagement app adds Telcare, Genesis (Press) (MedCity News)
  • SafeOp Surgical Receives FDA Clearance for EPAD Neuromonitoring Device (Press)
  • Food and Drug Administration/Xavier University Global Medical Device Conference (FDA)

US: Assorted And Government

  • "Hidden Trials" In The Age Of Transparency: ClinicalTrials.gov Director Sees Room For Improvement (RPM Report-$)
  • Waxman, Pallone want hearing on health research diversity (BioCentury)
  • Will Social Media Kill the Placebo Trial? (Ask CATO)
  • Be Careful What You "Like": Healthcare Industry Should Consider Privacy, Adverse Events, and Promotional Issues in Social Media Interactions (Policy and Medicine)
  • White House threatens veto of anti-regs bill (The Hill) (White House)
  • Honoring African American History by Increasing Access to Information Protecting and Promoting Your Health (FDA)

Upcoming Meetings And Events

  • Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • German bill extending price freeze to 2017 forces companies to reveal discounts (SCRIP-$)
  • Another French breast implant scandal erupts and spreads (Fierce)
  • EMA Releases Minutes of Most Recent CHMP Meeting (EMA)
  • EMA Touts Approval of 12 Medicines for Rare Diseases in 2013 (EMA)

India

  • Staff Changes at Indian Regulator Could Boost Review Processes in the Long Term (Emergo)
  • India moves closer to approving key medical device legislation (Fierce)
  • U.S. device makers laud India's new medtech proposal (Mass Device)
  • Indian drug regulator seen as corrupt: Roger Bate (India Times)
  • IDMA urges US FDA to reduce Generic Drug User Fee on Indian pharma exporters (PharmaBiz)

Japan & China

  • During Shanghai Visit PhRMA Chairman Calls For Regulatory Systems To Support Innovation (Pink Sheet-$)

Other International

  • Pharmaceutical companies express concerns about Canada revoking drug patents over their usefulness (The Hill)

General Regulatory And Interesting Articles

  • Open-Access Journal PLoS Creates Mandatory Open Data Policy (PLOS) (SBM)
  • The Secret to a Bulletproof Antidoping Test Might be Genes (NYTimes)
  • Mini-livers show promise to reduce animal use in science (NC3Rs)

Regulatory Reconnaissance #264 - 26 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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