Regulatory Focus™ > News Articles > Regulatory Recon: EU to Keep Pharma, Device Industries Under DG Sanco (23 October 2014)

Regulatory Recon: EU to Keep Pharma, Device Industries Under DG Sanco (23 October 2014)

Posted 23 October 2014 | By Alexander Gaffney, RAC

Regulatory Recon: EU to Keep Pharma, Device Industries Under DG Sanco (23 October 2014)

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

In Focus: US

  • Public Citizen Calls on FDA to Release Comments on Off-Label Information Proposal (Public Citizen)
  • Research without consent puts ethics to test (Portland Tribune)
  • FDA AdComm to Revisit Ban on Gay Blood Donors (FDA) (Tarius)
  • Oklahoma judge allows law banning abortion pills to take effect (Reuters)
  • Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices (MedDevice Online)
  • Will FDA Apply Its New Inspection Guidance to Other Products? (FDA Law Blog)

In Focus: International

  • EU Pharma Stays Under DG Health, But Growth Still On the Agenda (Pink Sheet-$) (PharmaTimes) (In-Pharma) (Reuters) (EFPIA)
  • Health Commissioner Vytenis Andriukaitis confirmed by European Parliament (EUnetHTA) (EuroParl)
  • NICE draft recommends Xarelto in ACS patients (BioCentury) (NICE) (PharmaPhorum) (PharmaTimes)
  • In Canada, Off-Label Prescribing of Antipsychotic Drug Highlights Lack of Oversight (Canadian Press)
  • Japan Opens Comment Period on New Patent Term Extension Rules for Drugs (JPO)
  • Drugmakers may need indemnity for fast-tracked Ebola vaccines (Reuters)
  • As researchers develop Ebola vaccine, early human clinical trials show promise (WaPo)
  • The Surprising Person You Might Want to Thank for All These Emerging Ebola Treatments: Dick Cheney (Bloomberg)

US: Pharmaceuticals and Biotechnology

  • Public Citizen Calls on FDA to Release Comments on Off-Label Information Proposal (Public Citizen)
  • Research without consent puts ethics to test (Portland Tribune)
  • FDA AdComm to Revisit Ban on Gay Blood Donors (FDA) (Tarius)
  • Anti-Infective Drugs Advisory Committee (AIDAC) to discuss clinical development programs and clinical trial designs for antibacterial products (Tarius)
  • Pfizer Recalling Torisel Injection Kits due to Potential for Crystallization Impurities (FDA)
  • An Update on Drug Shortages (Policy and Medicine)
  • Data Sharing in Pharmaceutical Industry Shows Progress (Rutgers)
  • Biogen Idec Suggests PML Risk Manageable For Tecfidera, After Reporting First Case (Pink Sheet-$) (MM&M) (BioCentury) (Fierce) (PharmaTimes) (AP) (CNBC) (BioFlash)
  • Citizen Petition request regarding evidence necessary to support approval for Abbreviated New Drug Application version of Prepopik. (FDA)
  • FDA Outreach to the Pediatric Cancer Advocacy Community (FDA)
  • Indian Co Zydus Recalls Topiramate Due to Presence of Incorrect Tablets (FDA)
  • Gyma Labs Recalls Several Drug Products After Italian Regulators Claim cGMP Issues (FDA)

U.S. court upholds patents on Pfizer's cancer drug (Reuters)

  • US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations
  • Regulus doubles on interim HCV data (BioCentury) (SCRIP-$) (The Street)
  • Relypsa seeks FDA nod for patiromer to treat hyperkalemia (SCRIP-$)
  • FDA Gives All-Clear to Cytori Therapeutics to Continue Trial After Safety Scare (Press)
  • MediciNova Announces FDA Granted Orphan Drug Designation to MN-001 (tipelukast) for Idiopathic Pulmonary Fibrosis (IPF) (Press)

US: Pharmaceuticals and Biotechnology: General

  • Oklahoma judge allows law banning abortion pills to take effect (Reuters)
  • Developing a systematic approach to safer medication use during pregnancy: summary of a Centers for Disease Control and Prevention--convened meeting (PubMed)

US: Medical Devices

  • Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices (MedDevice Online)
  • ReFlow Medical Corporation Announces FDA 510(k) Clearance and Initial US Clinical Use Of The Wingman35 Crossing Catheter (Press)
  • US: Dietary Supplements
  • NPA Sees Broad Impact While DoJ Argues Narrow Path On FTC’s Bayer Complaint (Tan Sheet-$)

US: Assorted And Government

  • What Can FDA Do During Drug Inspections: Will FDA Apply Its New Guidance to Other Products? (FDA Law Blog)
  • Ensuring Patient Privacy in Data Sharing for Postapproval Research (NEJM)

Upcoming Meetings

Ebola Outbreak

  • Drugmakers may need indemnity for fast-tracked Ebola vaccines (Reuters)
  • As researchers develop Ebola vaccine, early human clinical trials show promise (WaPo)
  • The Surprising Person You Might Want to Thank for All These Emerging Ebola Treatments: Dick Cheney (Bloomberg)
  • NIH Begins Early Human Clinical Trial of New Ebola Vaccine (DD&D) (The Hill)
  • Vaxart Accelerates Development of Ebola Tablet Vaccine (Press)
  • Tekmira starts manufacture of new RNAi therapeutic for Ebola (PharmaLetter-$)
  • EU earmarks $250 million to help develop Ebola vaccines: sources (Reuters)

Europe

Japan

  • Japan Opens Comment Period on New Patent Term Extension Rules for Drugs (JPO)

Canada

  • In Canada, Off-Label Prescribing of Antipsychotic Drug Highlights Lack of Oversight (Canadian Press)

Australia

  • TGA Upgrading Its Website (TGA)

Other International

  • Nigeria: NAFDAC Uncovers Illegal Production Facilities, Counterfeiters (AllAfrica)

General Regulatory And Interesting Articles

  • Commercial bioequivalence software in need of validation in wake of Thermo Scientific's review (BioPharma Reporter)
  • The man with the golden blood (MosaicScience)
  • Will we ever know if this widely-used contraceptive increases the risk of HIV infection? (The Verge)

Regulatory Reconnaissance #425 – 23 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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