Regulatory Focus™ > News Articles > Regulatory Recon: WHO Calls for Clinical Trials Transparency (15 April 2015)

Regulatory Recon: WHO Calls for Clinical Trials Transparency (15 April 2015)

Posted 15 April 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: WHO Calls for Clinical Trials Transparency (15 April 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

In Focus: International

  • WHO calls for all clinical trial results to be published (PMLive) (AllTrials) (Reuters) (Outsourcing Pharma) (WHO) (PLoS) (PLoS)
  • EMA Introduces New Measures to Prevent Medication Errors in the EU (EMA) (EMA) (EMA)
  • Health MEPs Propose Blueprint for Safer use of Antibiotics (EP)
  • Commission to publish details of EU product "safety feature" later this year (SCRIP-$)
  • Recent Trends In India's Clinical Research Approvals (24 Insight)
  • China To Clarify MRCT Regulatory Pathway Soon (PharmAsia-$)
  • Health Canada Launches New Drug and Product Inspections Database (HC)

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US: Pharmaceuticals and Biotechnology

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

  • AstraZeneca immune system drug wins orphan status in rare cancer (Reuters) (Press) (Pharmafile)
  • Teva and Eagle Pharmaceuticals Announce NDA for Bendamustine Rapid Infusion Product Accepted for Filing (Press)
  • Pfizer Announces PALOMA-3 Trial For IBRANCE (Palbociclib) Stopped Early Due To Efficacy Seen In Patients With HR+, HER2- Metastatic Breast Cancer Whose Disease Has Progressed Following Endocrine Therapy (Press)
  • Biogen MS Drug Results Are 'Mildly Encouraging' In Eye Disease Test (Forbes)
  • Heart Metabolics and FDA Reach Agreement on Special Protocol Assessment for Single Phase 3 Trial of Perhexiline in Hypertrophic Cardiomyopathy (Press)

US: Pharmaceuticals and Biotechnology: General

  • Feds to Probe Impact of Generic Drug Price Increases on Medicaid (Pharmalot) (Law 360-$)
  • Retail Generic Drug Inflation Eases, but the FDA Keeps Prices High (DrugChannels)
  • Groups Want Pricing Safeguards in NIH Patent Licensing Deal (KEI)
  • Costs From ‘Cures’ Bill's Breakthrough Provisions Worry Medicaid Directors (Pink Sheet-$)
  • Audit: Missouri Medicaid Failed To Bill Drugmakers For More Than $50M In Rebates (KHN)

US: Medical Devices

  • Perseon Announces FDA Clearance for Specific Indication of Non-Resectable Liver Tumor Ablation (Press)
  • Haag-Streit Surgical receives FDA 510(k) clearance for intraoperative-OCT camera (Press)
  • Conventus Orthopaedics Receives FDA Clearance for PH Cage, Proximal Humerus Implant Device (Press)

US: Dietary Supplements

  • FDA's CFSAN Director Says She's OK With States' Scrutiny of Supplements (NI-USA)
  • The New York Times Misplaces FDA Blame In Latest Dietary Supplement Spiking Episode (Forbes)
  • Durbin, Blumenthal Call on FDA to Investigate Supplement Makers in Growing Debate Over Amphetamine Substance (NPI)

US: Assorted And Government

  • New Batch of FDA Warning Letters Posted (FDA)
  • List of Environmentally Responsive Human Genes Selected for Use In Screening Large Numbers of Substances Using Toxicogenomic Approaches (NIH)
  • Rockpointe Launches New Life Science Compliance Update Publication (PolicyMed)
  • U.S. Tobacco Companies File Suit Against FDA Over Label Regulations (WSJ-$) (Reuters)
  • House Considering New Regulatory Transparency Legislation (CPR)
  • Assistant Attorney General Leslie R. Caldwell Delivers Remarks at the New York University Center on the Administration of Criminal Law’s Seventh Annual Conference on Regulatory Offenses and Criminal Law (DOJ)

Upcoming Meetings and Events

Ebola Outbreak

  • CDC begins Ebola vaccine trial in Sierra Leone (The Hill) (SCRIP-$) (CDC) (Press) (PharmaTimes)
  • Evaluating Clinical Trial Designs for Investigational Treatments of Ebola Virus Disease (PLoS)

Europe

  • EMA Introduces New Measures to Prevent Medication Errors in the EU (EMA) (EMA) (EMA)
  • Health MEPs Propose Blueprint for Safer use of Antibiotics (EP)
  • Commission to publish details of EU product "safety feature" later this year (SCRIP-$)
  • Swiss reg revision could spell medtech uncertainty as scrutiny increases over customer discount, incentives (Clinica-$)
  • Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product (EMA)
  • Draft qualification opinion of qualification of exacerbations of chronic pulmonary disease tool (EXACT), and EXACT-respiratory symptoms measure (E-RS) for evaluating treatment outcomes in clinical trials in chronic pulmonary disease (EMA)
  • EMA releases revision 48 of the Post-Authorisation Procedural Advice for Users of the CP (Exalon)
  • Medtronic Announces CE Mark of World's Smallest Pacemaker, Micra Transcatheter Pacing System (Press) (Mass Device) (MedGadget) (Grey Sheet-$) (Fierce)
  • PAD: Hansen Medical wins CE Mark for Magellan robot-assisted surgery platform (Mass Device)
  • Dutch take the lead on biosimilar switching - will others follow? (SCRIP RA-$)
  • MHRA Advertising Investigations (MHRA)

India

  • Recent Trends In India's Clinical Research Approvals (24 Insight)

China

  • China To Clarify MRCT Regulatory Pathway Soon (PharmAsia-$)

Canada

  • Health Canada Launches New Drug and Product Inspections Database (HC)

Australia

  • Australian TGA releases final eCTD specification, revises NeeS format (Exalon)

Clinical Trials

General Regulatory And Interesting Articles

  • Heart chip beats toward better drug screening, personalized medicine (Reuters)
  • 5 Practices for Managing Change When ISO 9001:2015 Arrives (GxP Lifeline)
  • Acetaminophen may dull your emotions (CBS)

Regulatory Reconnaissance #536 – 15 April 2015

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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