Regulatory Focus™ > News Articles > Regulatory Recon: China Pledges Drug Regulatory Reforms (7 January 2015)

Regulatory Recon: China Pledges Drug Regulatory Reforms (7 January 2015)

Posted 07 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: China Pledges Drug Regulatory Reforms (7 January 2015)

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

In Focus: US

  • Pharma Asks U.S. Supreme Court to Review County Take-Back Program (Pharmalot) (FDA Law Blog)
  • FDA integrating patient preference into device decisions (BioCentury)
  • FDA clears wider use of rapid test for influenza (Reuters) (Press) (FDA)
  • JAMA Editorials Provide Taste of LDT Regulation Debate to Come at Public Hearing (GenomeWeb)
  • Recalls Increase Slightly Third Year in a Row (FDAnews-$)
  • FDA: Patients deserve quality medications (FDA)
  • Drug Shortage in the U.S. May Pose Deadly Problem for Patients (TIME)

In Focus: International

  • China regulator to strengthen 'grim' food, drug safety control (Reuters)
  • NICE outlines process for developing biosimilars guidance (BioCentury)
  • NICE set to dismiss Millennium’s Crohn’s drug Entyvio (PMLive)
  • Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products (EMA)
  • India: D&C Amendment Bill proposes to constitute Medical Devices Technical Advisory Board (PharmaBiz)

US: Pharmaceuticals and Biotechnology

  • Pharma Asks U.S. Supreme Court to Review County Take-Back Program (Pharmalot) (FDA Law Blog)
  • Recalls Increase Slightly Third Year in a Row (FDAnews-$)
  • FDA: Patients deserve quality medications (FDA)
  • Drug Shortage in the U.S. May Pose Deadly Problem for Patients (TIME)
  • How should U.S. regulate powerful painkillers? (PBS)
  • Rep. Paulson: FDA Dragging its Feet on Approval of MenB Vaccine Bexsero (The Hill)
  • The US Food and Drug Administration's perspective on the new antidepressant vortioxetine (PubMed)
  • Aratana scores a 'first' with USDA approval for canine lymphoma drug (Fierce)
  • Man indicted for distributing unapproved medical products (NewsTribune)

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

  • Sunovion Pharmaceuticals Inc. Announces FDA Acceptance for Review of Supplemental New Drug Application for the Use of Aptiom (eslicarbazepine acetate) as Monotherapy Treatment for Partial-Onset Seizures (Press)
  • ContraVir Pharmaceuticals Granted FDA Meeting to Discuss Proposal for Phase 3 Trial of FV-100 (Press)
  • FDA Grants Soligenix "Fast Track" Designation for SGX301 for the First-Line Treatment of Cutaneous T-Cell Lymphoma (Press)
  • Gamida Cell's NiCord Receives FDA and EMA Orphan Drug Designation (Press)

US: Pharmaceuticals and Biotechnology: General

  • USC Football Team Doctor Admits To Ignoring FDA And NCAA Painkiller Regulations (VICE)
  • Safeway Fined Nearly $10M for Illegal Disposal of Waste - Including Pharmaceuticals (AP)
  • Vermont AG investigating generic drug price spikes (DSN)

US: Medical Devices

  • FDA integrating patient preference into device decisions (BioCentury)
  • FDA clears wider use of rapid test for influenza (Reuters) (Press) (FDA)
  • JAMA Editorials Provide Taste of LDT Regulation Debate to Come at Public Hearing (GenomeWeb)
  • MiMedx reveals subpoena, lawsuits against rivals, beefs with FDA (Mass Device)
  • Philips receives FDA 510(k) clearance for its latest Avalon CL Fetal Monitoring solution (Press)
  • NeuroSigma wins humanitarian designation from FDA for Monarch eTNS device (Mass Device)
  • FDA clears AmeriWater's MediQA dialysis system (Press)

US: Dietary Supplements

  • Ex-governor sentenced 2 years in steroid corruption scandal (SCRIP-$) (USA Today) (

US: Assorted And Government

  • Study: 2014 regs cost $181.5 billion (The Hill)
  • In Rememberance: Longtime CVM Veterinarian, Martin Robl (GB Tribune)

Upcoming Meetings

Ebola Outbreak

  • Chimerix' Brincidofovir Clinical Trial Starts at Ebola Center for Anti-Viral Drug (AP) (Reuters) (SCRIP-$)
  • Human trials of ‘prime and boost’ Ebola vaccine underway (PharmJournal-$)

Europe

  • NICE outlines process for developing biosimilars guidance (BioCentury)
  • NICE set to dismiss Millennium’s Crohn’s drug Entyvio (PMLive)
  • Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products (EMA)
  • Shockwave Medical Announces CE Mark Approval of its Lithoplasty System for the Treatment of Peripheral Artery Disease (Press) (Fierce)
  • Shield Therapeutics announces the acceptance for review by the European Medicines Agency of the Marketing Authorisation Application for Feraccr (Press)
  • Health claims divide EU supplement trade groups (NI-USA)

India

  • D&C Amendment Bill proposes to constitute Medical Devices Technical Advisory Board (PharmaBiz)
  • State FDA writes to NPPA to regulate price of cardiac stents (PharmaBiz)

China

  • China regulator to strengthen 'grim' food, drug safety control (Reuters)
  • China Works To Regulate The Difference Between Food And Traditional Chinese Medicine (Forbes)

Canada

  • Health Canada, Following Italy, Bans Products Manufactured by Sri Krishna Pharmaceutials (Health Canada) (India Times)
  • Canadian drug ads misleading: UBC prof (24HRS.CA)

Clinical Trials

  • How Can We Encourage Participation in Clinical Trials? (Forbes)

General Regulatory And Interesting Articles

  • Acne Becoming Drug Resistant (WSJ-$)
  • Gardasil HPV Vaccine Not Linked To Multiple Sclerosis Or Related Diseases (Forbes)
  • Risk Management: A Primer for Lean Quality Assurance (GxP Lifeline)
  • Pharmaceuticals, personal care products could taint swimming pools (Press)

Regulatory Reconnaissance #466 – 7 January 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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