Regulatory Focus™ > News Articles > Regulatory Reconnaissance: EU Vote on Clinical Trials Regulation Tomorrow (1 April 2014)

Regulatory Reconnaissance: EU Vote on Clinical Trials Regulation Tomorrow (1 April 2014)

Posted 01 April 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

In Focus: International

  • EU Vote on Clinical Trials Regulation Tomorrow (AllTrials)
  • EU Signals Start Of New Discussion On Mobile Health Regs (Gray Sheet-$)
  • EMA's Adaptive Licensing Policy: Broad Enthusiasm, Sparse Details (Pink Sheet-$)
  • Medtech makers warn on new EU rules (Mass Device)
  • Japanese regulators plan faster medical device registration process (Mass Device)
  • China Steps Up War On Counterfeit Drugs With Cancer Products In Focus (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • FDA panel votes in favor of approval for Cubist's, Durata's New Acute Bacterial Skin Infection Drugs (BioFlash) (Press) (SCRIP-$) (BioCentury) (RTT) (Reuters) (Fierce) (FPN)
  • Glaxo's Utter Stinkbomb Of A Drug (Forbes) (SCRIP-$) (Press) (Reuters)
  • Supreme Court Takes up Drug Company Dispute (AP) (NYTimes) (Law 360-$) (Patent Docs) (BioCentury) (Fierce) (SCOTUSblog) (Press)
  • Will US track and trace law be enough to stop counterfeiters? (In-Pharma)
  • Hardy case shows flaws in compassionate use system, provides catalyst for change (BioCentury)
  • How Chimerix, FDA grappled with providing compassionate access to Josh Hardy (BIoCentury) (BioCentury) (BioCentury)
  • Afrezza Gets Third Try at FDA (MedPage Today)
  • BioCentury checklist for an equitable compassionate access system (BioCentury)
  • As Food and Drug Imports Increase, FDA Focuses on Becoming Global Health Organization (Roll Call)
  • Enhanced FDA Tracking System to Monitor for Counterfeits, Contamination (Roll Call)
  • Patent Extensions for Prevnar-13 and Nulojix (FDA) (FDA)
  • Hamburg on Pretty Much Everything FDA is Doing Right Now (FDA)
  • Upcoming House Hearing: Improving Predictability and Transparency in DEA and FDA Regulation (E&C)
  • FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension (FDA)
  • CROs debate: Can surrogate endpoints speed oncology drugs to market? (Outsourcing Pharma)
  • FDA Defends Push For Use Of FDA-Registered Outsource Compounders (IHP-$)
  • FDA Schedules Pediatric AdComm (FDA)
  • Chinese Drug Manufacturer Shanghai Life-Beauty Cosmetics Co. Put on Import Alert Over CGMP Deficiencies (FDA)
  • Doctors criticise FDA over Lemtrada rejection (PMLive)
  • How Changes To 'Dear Doctor Letters' Will Impact Industry (Law 360-$)
  • Federal judge will not block Arizona rules limiting use of abortion drugs (Reuters) (NYTimes)
  • Important unknowns about Novartis's potential paradigm shifter LCZ696 (SCRIP-$)
  • CompPharma Research on Compounded Drugs Questions their Efficacy, Safety and Cost (Press)
  • "Right to Try" aims to limit bureaucracy for Colorado's terminally ill (Denver Post)

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

  • Janssen Submits New Drug Application to FDA for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat as Part of Combination HIV Therapy (Press)
  • Halozyme's Diabetes Drug Meets Primary Endpoint (Press)
  • FDA Grants Orphan Designation to Kite Cancer Immunotherapy (Press)

US: Pharmaceuticals and Biotechnology: General

  • Incoming Princeton Freshmen to Receive Meningitis Vaccine (NBC)

US: Medical Devices

  • The Device Makers' Shortcut (NYTimes)
  • Major mismatch: 1 in 3 clinical trials reports inconsistent adverse events, researchers say (Mass Device)
  • UDI and GUDID Compliance: Start Planning Now (MDDI)
  • Intuitive Surgical Gets FDA Clearance for New da Vinci Robotic System (WSJ-$)

US: Assorted And Government

  • Obama's regs chief: We're not setting policy (The Hill)
  • Rep. Dave Camp, Member of E&C Committee, to Retire (WaPo)

Europe

  • EU Vote on Clinical Trials Regulation Tomorrow (AllTrials)
  • EU Signals Start Of New Discussion On Mobile Health Regs (Gray Sheet-$)
  • EMA's Adaptive Licensing Policy: Broad Enthusiasm, Sparse Details (Pink Sheet-$)
  • Medtech makers warn on new EU rules (Mass Device)
  • UK Parliamentary Report on Clinical Trials Transparency (UK)
  • Portable tech advancing fight against counterfeits, says MHRA (In-Pharma)
  • UK clinical trials system not working during epidemics (Pharmafile)
  • France Publishes New Financial Penalties for Noncompliance (ANSM)

India

  • FDC manufacturers to present their case before DCGI on safety and efficacy (PharmaBiz)

Japan & China

  • Japanese regulators plan faster medical device registration process (Mass Device)
  • China Steps Up War On Counterfeit Drugs With Cancer Products In Focus (PharmAsia-$)
  • Japan MHLW/MEXT Draft Ethical Guidelines That Would Require Third Party Monitoring (PharmAsia-$)
  • GE recalls hundreds of baby 'warmers' in China over safety fears (Reuters)

General Regulatory And Interesting Articles

  • A Bandage That Senses Tremors, Delivers Drugs, and Keeps a Record (MIT Tech Review)
  • Blood test helps rule out heart attack in ER with 99-percent accuracy (CBS)

Regulatory Reconnaissance #288 - 1 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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