Regulatory Focus™ > News Articles > Regulatory Recon: FDA Confirms Role in Facilitating Ebola Drug Access (21 August 2014)

Regulatory Recon: FDA Confirms Role in Facilitating Ebola Drug Access (21 August 2014)

Posted 21 August 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Confirms Role in Facilitating Ebola Drug Access (21 August 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

In Focus: International

  • Tekmira's Experimental Drug Used for Ebola-Related Virus Shows Promise (NYTimes) (SCRIP-$) (BioWorld) (LA Times) (WaPo) (NBC) (AP) (Bloomberg)
  • EU drug regulators caution: Interferon beta MS drugs may damage kidneys, other organs (Reuters)
  • EMA to Limit Use of Bromocriptine-Containing Medicines due to Safety Concerns (EMA)
  • 20% of Clinically Effective Drugs are not Reimbursed— Here's Why (Context Matters)
  • More NGOs unite against the EC chief scientific advisor role (Nutra Ingredients)
  • Calls for India to Regulate Medical Devices (PharmaBiz)
  • ICH Releases New Documents (ICH) (ICH) (ICH)

US: Pharmaceuticals and Biotechnology

  • U.S. judge sides with Hospira in generic Precedex patent lawsuit (Reuters) (BioCentury) (FDA Law Blog) (Law 360-$) (Pink Sheet-$) (WSJ-$)
  • The Role Of Black Box Warnings In Safe Prescribing Practices (Health Affairs)
  • FDA Approval of Bedaquiline — The Benefit–Risk Balance for Drug-Resistant Tuberculosis (NEJM)
  • DTC and Regulatory Enforcement (EyeonFDA)
  • GSK receives FDA approval for Arnuity Ellipta (fluticasone furoate) in the US for the treatment of asthma (Press) (SCRIP-$)
  • Depomed scores a win in its epic struggle to fend off Gralise copycats (Fierce)
  • Nexium Buyers Say Ranbaxy Should Turn Over Regulatory Docs In MDL (Law 360-$)

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

  • After strong trials, Lilly to seek approvals for psoriasis drug (IBJ) (Press) (Reuters) (Newscred)
  • Auxilium drug found effective against cellulite in mid-stage study (Reuters)

US: Medical Devices

  • Type 1 Diabetes Antibody Test Gains FDA Nod (FDA) (BioCentury) (MedPage Today)
  • Hack Attack On Hospital System Highlights Need For Device Cybersecurity (Gray Sheet-$)
  • Shareholders sue InVivo Therapeutics, ex-CEO Reynolds over delayed FDA trial (Mass Device)
  • How can you be sure a medical app actually works? (NPR)
  • FDA Approves Changes to Manufacturing Process for Covidien’s Pipeline Embolization Device (Press)
  • Philips receives FDA 510(k) Clearance for TAVI Precision Treatment Planning Application (Press)
  • AliveCor Receives First FDA Clearance to Detect a Serious Heart Condition in an ECG on a Mobile Device (Press) (MobiHealth News)
  • Covidien's atherectomy study finally hits JACC (Mass Device)
  • DePuy Recalls Craniomaxillofacial Distraction System (FDA)

US: Dietary Supplements

  • Blumenthal Seeks US Rules On Powdered Caffeine (AP)
  • U.K. Supplement Retailer’s “Suitable” Customer Advice Likely Unsuitable In U.S. (Tan Sheet-$)
  • Half of hospital patients fail to disclose dietary supplement use (NI-USA)

US: Assorted And Government

  • Chinese Hackers Vacuum Data From U.S. Health Industry (Bloomberg)
  • FDA Enforcement Report (FDA)
  • FDA Looking to Hire Help for Diversity Training (FDA)

Ebola Outbreak

  • Tekmira's Experimental Drug Used for Ebola-Related Virus Shows Promise (NYTimes) (SCRIP-$) (BioWorld) (LA Times) (WaPo) (NBC) (AP) (Bloomberg)
  • FDA Official Confirms Emergency IND Process Used to Facilitate Use of Zmapp in Atlanta (Medscape)
  • Demand for an Ebola vaccine is higher than you might think. Scientists say 30K people need one (Reuters)
  • Studying “Secret Serums” — Toward Safe, Effective Ebola Treatments (NEJM)
  • U.S. hospital to discharge doctor treated with experimental Ebola drug (Reuters) (NBC)
  • UK and Wellcome offer $10 million for emergency Ebola research (Reuters)

Europe

  • EU drug regulators caution: Interferon beta MS drugs may damage kidneys, other organs (Reuters)
  • EMA to Limit Use of Bromocriptine-Containing Medicines due to Safety Concerns (EMA)
  • NICE: 20% of Clinically Effective Drugs are not Reimbursed— do you want to know why? (Context Matters)
  • More NGOs unite against the EC chief scientific advisor role (Nutra Ingredients)
  • IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis (Pharma Letter-$) (SCRIP-$)
  • Sovaldi and the politics of high-priced drugs: are we asking the right questions? (PharmaPhorum)
  • European Medicines Agency accepts Basilea's isavuconazole Marketing Authorization Application for review (MarketWatch)
  • EMA Releases EPAR for Gazyvaro (EMA)

India

  • Industry wants CDSCO to work with states to weed out corruption & bring accountability in the system (PharmaBiz)
  • Govt should bring in medical device regulation to prevent sale of substandard devices: Sanjay Arudi (PharmaBiz)

China

  • China FDA Requests Changes To Meropenem Use Manual (PharmAsia-$)

Canada

  • Health Canada approves drug for rare disorder but will Ontario? (Global News)

Other International

  • ICH: Genomic Sampling Methodologies for Future Use (ICH)
  • ICH: General principle on planning/designing Multi-Regional Clinical Trials (ICH)
  • ICH: E11 (R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population (ICH)

Clinical Trials

  • Will Adaptive Design Become the New Paradigm for Cancer Trials? (Reuters)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #383 – 21 August 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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