Regulatory Focus™ > News Articles > Regulatory Recon: FDA Openly Criticizes EMA's Ebola Plan (31 October 2014)

Regulatory Recon: FDA Openly Criticizes EMA's Ebola Plan (31 October 2014)

Posted 31 October 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Openly Criticizes EMA's Ebola Plan (31 October 2014)

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

In Focus: US

  • FDA Panel Backs Daiichi's A-fib Drug Edoxaban (Fierce) (Medscape) (Tarius) (MedPage Today) (Press) (SCRIP-$) (BioCentury) (Pink Sheet-$)
  • FDA Makes Highly Unusual Statement Regarding Sarepta's NDA for Eteplirsen (FDA) (WSJ-$) (Fierce)
  • FDA Hopes to Release MAPP This Year to Improve Communications With Generics Firms (FDA News-$) (Lachman)
  • Regulatory Expert: 510(K) Not Appropriate Pathway For 3-D Printing (MDDI)
  • Industry Calls on FDA To Relax Pediatric Device Requirements (Gray Sheet-$)
  • Johnson & Johnson weighs $250M settlement to resolve more hip implant claims (Fierce)

In Focus: International

  • Europeans’ Plan to do Uncontrolled Ebola Trial Draws Fire from FDA (WSJ-$)
  • EU Court Judgment On Generic Authorizations Could Increase Litigation (Pink Sheet-$)
  • Strategy for EU Cooperation onHealth Technology Assessment (European Commission)
  • Italian Regulators Issue Non-Compliance Report to Chinese Pharmaceutical Company (EudraGMP)
  • Experts slam crippling Indian trial regulations (SCRIP-$)
  • The Registration Process of Ethiopia (Arazy)

US: Pharmaceuticals and Biotechnology

  • FDA Panel Backs Daiichi's A-fib Drug Edoxaban (Fierce) (Medscape) (Tarius) (MedPage Today) (Press) (SCRIP-$) (BioCentury) (Pink Sheet-$)
  • FDA Makes Highly Unusual Statement Regarding Sarepta's NDA for Eteplirsen (FDA) (WSJ-$) (Fierce)
  • FDA Hopes to Release MAPP This Year to Improve Communications With Generics Firms (FDA News-$) (Lachman)
  • Evolution of the food and drug administration approach to liver safety assessment for new drugs: current status and challenges. (PubMed)
  • Did Novartis Make a Ham-Handed Move to Promote an Antibiotic for Pigs? (Pharmalot)
  • Zogenix and Purdue Pharma Exchange Waivers of Regulatory Exclusivity for Extended-Release Hydrocodone Products (Press)
  • FDA Posts Advisory Committee Materials on Viral and Bacterial Shedding Guidance and the Dear Gene Therapy IND or Master File Sponsor Letters (Tarius)
  • Withdraw FDA scientific pubs distribution guide: Public Citizen (MM&M)
  • Reservations about study on antidepressant use by young people and suicidal behaviour after FDA warnings (PubMed)
  • FDA Regulation in the Data-Driven Economy (PPI)
  • Turkish man sent to prison for smuggling fake Avastin into U.S. (Fierce)
  • Industry Divided on Need for Naming Reservation Program (FDA News-$)
  • FDA Approves Generic Alzheimer's Drug (DD&D)
  • NY lawmakers urge DOJ to allow access to medical marijuana for kids (The Hill)
  • Patient Groups Band Together on Biosimilar Safeguards (PBSA)
  • FDA Releases New List of Drugs Eligible for Generic Competition (FDA)
  • Veloxis announces tentative approval of Envarsus XR (Press)

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

  • BMS' PD-1 blocker Opdivo aces lung cancer trial (PMLive) (SCRIP-$) (PharmaTimes)
  • Avanir Pharmaceuticals Announces Publication of Pivotal Phase III Results from AVP-825 Acute Migraine Study in the Journal "Headache" (Press)

US: Pharmaceuticals and Biotechnology: General

  • Life Sciences Groups Assail SF’s Drug 'Take-Back' Plan (Law 360-$)
  • Three Reasons to Adopt Unit-Level Traceability Now (PCM)
  • BARDA: The venture capital firm buried in the U.S. government (MarketPlace)
  • Senators Call for More Funding for BARDA (Press)

US: Medical Devices

  • Regulatory Expert: 510(K) Not Appropriate Pathway For 3-D Printing (MDDI)
  • Industry Calls on FDA To Relax Pediatric Device Requirements (Gray Sheet-$)
  • Johnson & Johnson weighs $250M settlement to resolve more hip implant claims (Fierce)
  • Abiomed jumps on FDA deal for Impella indication (Mass Device)
  • RenovoCath RC120 Catheter Receives FDA Clearance (Press)

US: Dietary Supplements

US: Assorted And Government

  • Weekly FDA Enforcement Report (FDA)

Upcoming Meetings

Europe

India

  • Experts slam crippling Indian trial regulations (SCRIP-$)
  • CDSCO forms 5-member panel headed by Dr. Jagashetty to review manpower structure of CDL, Kolkata (PharmaBiz)

Canada

  • Health Canada Releases Monthyl Adverse Reaction Newsletter (Press)

Other International

  • The Registration Process of Ethiopia (Arazy)
  • Boosting drugs manufacture in developing countries will improve health outcomes, UN investment forum told (PharmJournal)

Clinical Trials

  • Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials (PubMed)

General Regulatory And Interesting Articles

  • The kindest cut: my journey into the nether regions of male birth control (The Verge)
  • Blood-Brain Barrier Opened With Ultrasound Implants to Let Drugs Through (MedGadget)
  • Penicillin allergy rates may be wildly overestimated (PharmJournal)
  • Why some animals have blue, green, or purple blood (Vox)
  • Off With Their Heads! BioSpace's Favorite CEOs Who Got The Axe In 2014 (BioSpace)

Regulatory Reconnaissance #431 – 31 October 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.


Categories: Recon, Regulatory News

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