Regulatory Focus™ > News Articles > Regulatory Reconnaissance: EMA Database of 'Warning Letters' Unveiled (6 January 2013)

Regulatory Reconnaissance: EMA Database of 'Warning Letters' Unveiled (6 January 2013)

Posted 06 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

  • Sponsors Get Six-Month Reprieve On Electronic Filings For NDAs, ANDAs, BLAs, INDs (Pink Sheet-$)
  • ANDA Review Consistency Could Emerge As A GDUFA Problem (Pink Sheet-$)
  • FDA Plans New Safety Assessment Of Dabigatran (Pradaxa) (Forbes) (SCRIP-$) 
  • Multiple Options To Weigh For Moving A UDI Into FDA's Database (Gray Sheet-$)
  • FDA issues warning on Vital Signs' anesthesia devices (Mass Device)

In Focus: International

  • EMA identifies GMP transgressors in public database (Pharmafile)
  • ABPI Chief Calls for Regulatory Temperance (Pharmafile)
  • Indian Health ministry to amend D&C Rules to include new drug delivery systems as new drug (Pharmabiz)
  • In whom we trust: the role of certification agencies in online drug markets (AEI)

US: Pharmaceuticals/Biotechnology

  • Sponsors Get Six-Month Reprieve On Electronic Filings For NDAs, ANDAs, BLAs, INDs (Pink Sheet-$)
  • ANDA Review Consistency Could Emerge As A GDUFA Problem (Pink Sheet-$)
  • FDA Plans New Safety Assessment Of Dabigatran (Pradaxa) (Forbes)
  • Generic Drugs 2014: OGD Creates Internal Review Goals, May Make OND-Inspired Changes (Pink Sheet-$)
  • New Drugs In 2013 Show A Virtuous Cycle: First-Cycle Approvals Up, Review Times Down (Pink Sheet-$)
  • Mylan Comments on Gilead's Stribild Citizen Petition for Five-Year NCE Exclusivity (FDA Lawyers Blog)
  • CLINIMIX and CLINIMIX E Injection/Baxter: Recall - Particulate Matter in Products (FDA)
  • Baxter Initiates Nationwide Voluntary Recall of Select Lots of Premix Parenteral Nutrition (FDA)
  • FDA Investigators Search For Silver Bullets In Off-Label Probes (Pink Sheet-$)
  • Supreme Court Rejection of Pfizer's Request for RICO Off Label Review: Could Open Floodgate of Cases (Policy and Medicine)
  • Travelers Told To Hand Heparin Docs To American Capital (Law 360-$)
  • Boehringer, Teva Sued Over $120M Pay-For-Delay Deal (Law 360-$)

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

  • Peregrine Pharmaceuticals Receives FDA Fast Track Designation for Its Immunotherapy Bavituximab as a Potential Treatment of Second-Line Non-Small Cell Lung Cancer (Press)
  • RegeneRx Receives Orphan Drug Designation for Tβ4 in the Treatment of Neurotrophic Keratopathy (Press)
  • Organ Regeneration Company Files Pre-IND Request with FDA (Press)
  • InVivo Sends Amended Protocol to FDA and Six Clinical Sites (Press)

US: Pharmaceuticals and Biotechnology: General

  • How a drug for few patients was turned into $81 million in sales (Seattle Times) (Video)
  • Prices Rising - Every Year, Every Drug? (In the Pipeline)
  • GPhA Uses Generic Drug Savings Report To Bolster Position In TPP Talks (IHP-$)
  • Gene Patent Case Fuels U.S. Court Test of Stem Cell Right (Bloomberg)

US: Medical Devices

  • Multiple Options To Weigh For Moving A UDI Into FDA's Database (Gray Sheet-$)
  • mHealth Coalition Counters Blackburn Push Against Health IT Regs (Gray Sheet-$)
  • Medical device industry: This CEO will spend his 2014 helping your FDA odds (MedCity News)
  • FDA issues warning on Vital Signs' anesthesia devices (Mass Device)
  • Another insurer accuses Intuitive Surgical of concealing legal claims over da Vinci surgical robot (Mass Device)
  • Whistleblower lawsuit costs Genzyme $22M (Mass Device)
  • InVivo lands FDA approval to begin trial of spinal scaffold (Mass Device)
  • Class 1 Recall: Covidien's Puritan Bennett 840 ventilator systems software (FDA)

US: Dietary Supplements

  • Supplement Groups Seek Hill Champions For DSHEA Defense in 2014 (Tan Sheet-$)

US: Assorted And Government

  • Twenty-Sixth Update of the Federal Agency Hazardous Waste Compliance Docket (EPA)
  • Updated Version of HP&M Fraud and Abuse Outline Covers Devices as Well as Drugs (FDA Law Blog)
  • Environment for Appropriations Still Difficult and Tight (Strengthen FDA)
  • US Capitol Capsule: Congress returns, FDA sets agenda, ACA underway: Washington embarks on 2014 (SCRIP-$) 

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

  • EMA identifies GMP transgressors in public database (Pharmafile)
  • ABPI Chief Calls for Regulatory Temperance (Pharmafile)
  • Draft guideline on core summary of product characteristics for plasma-derived fibrin sealant / haemostatic products (EMA)
  • NPS Pharmaceuticals Receives Orphan Drug Designation for Natpara in Europe (Press)

Asia

  • Indian Health ministry to amend D&C Rules to include new drug delivery systems as new drug (Pharmabiz)
  • Daiichi Sankyo Files Edoxaban For Venous Thromboembolism And Non-valvular Atrial Fibrillation In Japan (PharmAsia-$)

General Regulatory And Interesting Articles

  • In whom we trust: the role of certification agencies in online drug markets (AEI)
  • Bad Statistics, and Bad Training, Are Sabotaging Drug Discovery (Xconomy)

Regulatory Reconnaissance #229 - 6 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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