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  • Article

    Advanced Therapy For Melanoma Receives Positive Opinion

    On October 23, 2015, the CHMP recommended authorizing Imlygic (talimogene laherparepvec) for the treatment of adults with melanoma that cannot be removed by surgery...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    Call For Expression Of Interest Opens For EMA Management Board

    The European Commission is launching a selection procedure to appoint the Civil Society representatives in the Management Board of the EMA in London.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    CJEU Decides Landmark Stem Cell Patentability Case

    The European Court of Justice recently held that a nonfertilized human ovum, the development of which has been stimulated by parthenogenesis should not be regarded as a human embryo within the meaning of the EU Biotech Directive.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    CMDh Endorses Revocation Of Authorizations For Fusafungine Sprays

    Following the CMDh consensus position, EU Member States will begin revoking the marketing authorizations of these medicines in their territories according to an agreed timetable.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EFSA Consults On Draft TCC Report

    EFSA and the World Health Organization have published the draft conclusions and recommendations of their joint workshop on the Threshold of Toxicological Concern approach.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EFSA Launches Public Consultation On Health Claims Related To Gut And Immune Function

    On February 9, 2015, EFSA launched a public consultation giving stakeholders and other interested parties the opportunity to comment on the draft update of its guidance for health claims related to gut and immune function.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EFSA Opens Magnesium Consultation

    The draft opinion proposes adequate intakes based on observed intakes in healthy populations in the EU.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EFSA Updates Guidance On How To Prepare A Health Claims Application

    It also details the kind of information and data applicants need to submit in support of their claim.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EMA Issues Recommendations To Minimize Risk Of Rare Brain Infection PML With Tecfidera

    On October 23, 2015, the CHMP gave new advice for doctors and patients in order to minimize the risk of progressive multifocal leukoencephalopathy in patients treated with the multiple sclerosis medicine Tecfidera.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EU Commission Issues Regulation Rejecting Certain Glucose Claims

    On January 6, 2015, certain health claims relating to glucose were rejected by Commission Regulation (EU) 2015/8 of 6 January 2015...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EU Commission Publishes FAQs On European Reference Networks

    On October 6, 2015, the European Commission published frequently asked questions on the procedural aspects on establishing European Reference Networks.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Authorities Issue Guidance On Nanomaterials, Pharmacovigilance

    The European Commission and the Scientific Committee on Emerging Newly Identified Health Risks have published guidance on determining potential health effects of using nanomaterials in medical devices.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission Authorizes A Health Claim On Cocoa Flavanols

    On March 31, 2015, the European Commission issued Commission Regulation (EU) 2015/539 authorizing the following health claim...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission, EMA, And WHO Step Up Cooperation

    The aim of the new working arrangement is to strengthen communication between the respective organizations and make it easier to take action to protect public health.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission Rejects Certain Food Claims Relating To The Development And Health Of Children

    On March 9, 2015, the European Commission issued Commission Regulation (EU) 2015/391 of March 9, 2015, refusing to authorize certain health claims made on foods and referring to children's development and health.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission Rejects Certain Health Claims On Foods

    On March 11, 2015, the European Commission issued Commission Regulation (EU) 2015/402 of 11 March 2015, refusing to authorize certain health claims made on foods...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Court Hands Down Judgment In Medical Device Case

    The Bundesgerichtshof asked the Court of Justice whether the device may be classified as defective based solely on evidence that quality control checks on devices of the same model disclosed a potential defect.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Parliament Calls For Limit On Industrial Trans Fats In Food

    On October 26, 2016, Members of European Parliament ("MEPs") resolved to place mandatory limits on industrially produced trans-fatty acids ("TFAs").
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Pharma Groups Launch Clinical Trial Tool To Avoid Duplicate Enrollments

    The European Federation of Pharmaceutical Industries and Associations and Innovative Medicines Initiative announced the launch of NewMeds new tool for avoiding duplicate enrollment of patients in clinical trials.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Trade Group Disfavors Sponsorship Of Health Care Professionals At Conferences

    This development illustrates the medical device industry's focus on high ethical standards for industry–health care professional relationships.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Showing 1–20 of 28574 results

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