Regulatory Focus™ > News Articles > Regulatory Recon: EMA Says Ebola Treatments Need More Study (17 December 2014)

Regulatory Recon: EMA Says Ebola Treatments Need More Study (17 December 2014)

Posted 17 December 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: EMA Says Ebola Treatments Need More Study (17 December 2014)

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

As a notice to our readers, Regulatory Focus and Regulatory Reconnaissance will be on holiday break starting 22 December 2014. We will return—well rested, we hope—on 5 January 2015 with a roundup of all the news we missed during those two weeks.

In Focus: US

  • Pharmacy owners arrested in '12 meningitis outbreak (AP)
  • Target selection for FDA-approved medicines (PubMed)
  • Veloxis sues FDA over tacrolimus delay (BioCentury) (Press)
  • FDA approves Ipsen's Somatuline Depot for GEP-NETs (BioCentury) (PharmaTimes) (Press) (SCRIP-$)
  • FDA Issues Guidance on “Patient Counseling Information” (FDA) (JDSupra) (FR)
  • FDA to Industry: Are you ready for the Drug Supply Chain Security Act? (FDA)
  • F.D.A. Approves System That May Make Blood Transfusions Safer (NYTimes) (Press) (Reuters) (FDA)
  • Providers Want Feds To Better Standardize Unique Device IDs (Gray Sheet-$)
  • Customed Adds Another 179 Devices to Largest-Ever Class 1 Recall (FDA)

In Focus: International

  • EMA says much more info needed on Ebola meds (PharmaTimes) (EMA) (WSJ-$)
  • EMA Selects First Group of Applicants for Adaptive Pathway Pilot (EMA) (FDA News-$) (Pharmafile)
  • EU Ombudsman in Favor of Trials Transparency Re-Elected to Another Term (EuroParl) (EuroParl)
  • ICH Releases Three New Guidance Documents (Q11 Q&A) (Q3A-Q3D) (S11)
  • "Ibero-American network" brings regulators closer together (SCRIP-$)

US: Pharmaceuticals and Biotechnology

  • Pharmacy owners arrested in '12 meningitis outbreak (AP)
  • Target selection for FDA-approved medicines (PubMed)
  • Veloxis sues FDA over tacrolimus delay (BioCentury) (Press)
  • FDA approves Ipsen's Somatuline Depot for GEP-NETs (BioCentury) (PharmaTimes) (Press) (SCRIP-$)
  • FDA Issues Guidance on “Patient Counseling Information” (FDA) (JDSupra) (FR)
  • FDA to Industry: Are you ready for the Drug Supply Chain Security Act? (FDA)
  • Draft Guidance: Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion (FDA)
  • VICH Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data (FDA) (FR)
  • Funding Extended For Reagan-Udall Foundation for the FDA Tuberculosis Drug Regimen Development Project (RUF)
  • Fourth Circuit Rolls Back District Court Decision on Pre-MMA 180-Day Exclusivity for Generic CELEBREX (FDA Law Blog)
  • FDA Head Speaks Up for Science (Union of Concerned Scientists)
  • United States Food and Drug Administration and Department of Defense shelf-life extension program of pharmaceutical products: progress and promise (PubMed)
  • What’s New with CDISC Standards? (BioClinica)
  • In praise of FDA collaboration: the cardiac safety example (HealthBusinessBlog)
  • Pozen says FDA rejects two forms of its lead drug, shares fall (Reuters) (Press) (SCRIP-$)
  • FDA Issues Warning Letter to Repromed Fertility Center (FDA)
  • FDA Wants to Upgrade its Regulatory Science Facility (FDA)
  • Retiring Rep. Waxman Posts Throwback Photos of Passage or Orphan Drug Act (Waxman)
  • For J&J OTC Sales, Tylenol Arthritis Label Approval Could Bring Relief Closer (Tan Sheet-$)

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

  • Bayer Submits Application for U.S. FDA Approval for Recombinant Factor VIII Product (BAY 81-8973) for the Treatment of Hemophilia A in Adults and Children (Press)
  • Auspex's Huntington's drug hits the mark in Phase III (Fierce) (BioCentury) (PharmaTimes) (The Street) (Reuters)
  • Cyclacel's cancer drug isn't working in Phase III, but that won't stop the trial (Fierce)
  • CASI Pharma Granted Type C Meeting With FDA For ENMD-2076 In FLC (Press)

US: Pharmaceuticals and Biotechnology: General

  • The 11 biggest drug launches to watch in 2015 (BioPharmaDive)
  • National Survey Finds Teen Abuse of OTC Cough Medicine At All-Time Low (Press)
  • Cigna Admits Gilead's Sovaldi Highly Effective in Real-World Settings (Press)
  • Top 30 Pharma Companies Spent $112B on R&D in 2013 (PharmPro)
  • Abuse Of Synthetic Drugs Declines Across U.S. (NPR)

US: Medical Devices

  • F.D.A. Approves System That May Make Blood Transfusions Safer (NYTimes) (Press) (Reuters) (FDA)
  • Providers Want Feds To Better Standardize Unique Device IDs (Gray Sheet-$)
  • Customed Adds Another 179 Devices to Largest-Ever Class 1 Recall (FDA)
  • FDA Issues Warning Letter to Karl Storz (FDA)
  • FDA Issues Warning Letter to Voss Plastics (FDA)
  • Class 2 Recall for 28 Instrumed Int. Devices (FDA)
  • Bruker to pay $2.4m to settle SEC charge of improper payments in China (BioPharma Reporter)
  • iGrow Hair Growth System Receives FDA Over-the-Counter Clearance for Women (Press)

US: Dietary Supplements

  • FDA Warns Against Using Caffeine Powder (WSJ-$) (FSN) (FDA)

US: Assorted And Government

  • After FDA Smallpox Scare, Feds Conclude Sweep of Federal Labs (Washington Post)
  • Continuing Medical Education Payments To Physicians Will Be Exposed To Sunshine (Forbes)

Upcoming Meetings

Ebola Outbreak

Europe

  • EMA Selects First Group of Applicants for Adaptive Pathway Pilot (EMA) (FDA News-$) (Pharmafile)
  • EMA says much more info needed on Ebola meds (PharmaTimes) (EMA) (WSJ-$)
  • EU Ombudsman in Favor of Trials Transparency Re-Elected to Another Term (EuroParl) (EuroParl)
  • Guideline on quality of transdermal patches (EMA)
  • From generics to biosimilars: relevant EU legislation (ILO)
  • BI's Pradaxa available on the NHS for blood clots (PharmaTimes) (Pharmafile) (Press)
  • Human antithrombin III concentrate (0878): Rapid implementation of corrected monograph (EDQM)
  • CVRx Barostim neo Now Cleared for MRI Use in Europe (MedGadget)

India

  • India Talks Up Regulatory Revamp (PharmAsia-$
  • IPC initiates work on Addendum 2016 & 53 monographs already identified by experts (PharmaBiz)

Canada

  • Health Canada Calls for Warning Label on Hysterectomy Tool (WSJ-$)

Other International

  • ICH Releases Three New Guidance Documents (Q11 Q&A) (Q3A-Q3D) (S11)
  • "Ibero-American network" brings regulators closer together (SCRIP-$)

Clinical Trials

General Regulatory And Interesting Articles

  • H1N1 Pandemic vs. Ice Bucket Challenge: Which Was More Infectious? (MPR)

Regulatory Reconnaissance #461 – 17 December 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.

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.


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