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BfArM - Federal Institute for Drugs and Medical Devices

    https://www.bfarm.de/EN/Home/_node.html
    The BfArM is the largest drug approval authority in Europe. Experts contribute their knowledge to the scientific committees of the European Medicines Agency ( EMA ), …

BfArM - Medical devices

    https://www.bfarm.de/EN/Medical-devices/_node.html
    BfArM Recommendations include information about risks arising from medical devices and measures recommended by the Federal Institute in order to reduce or eliminate risks. …

Federal Institute for Drugs and Medical Devices (BfArM)

    https://www.bundesgesundheitsministerium.de/en/en/ministry/authorities-within-the-remit/federal-institute-for-drugs-and-medical-devices-b.html
    The main tasks of the Federal Institute for Drugs and Medical Devices involve the central collection, analysis and assessment of risks resulting from the application or use of …

BfArM - Clinical investigations and performance studies

    https://www.bfarm.de/EN/Medical-devices/Tasks/Clinical-investigations-and-performance-studies/_node.html
    The Federal Institute for Drugs and Medical Devices (BfArM) offers a contact point for subjects participating in a clinical investigation of a medical device / performance study …

Federal Institute for Drugs and Medical Devices - Wikipedia

    https://en.wikipedia.org/wiki/Federal_Institute_for_Drugs_and_Medical_Devices
    The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) is the medical regulatory body in Germany. It …

BfArM - Federal Institute for Drugs and Medical Devices

    https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/Servicesuche_Formular.html?cl2Categories_Format=risikoinformation+download+news+formular+risikobewertungsverfahren&cl2Categories_Rubrik=bundesopiumstelle
    BfArM - Federal Institute for Drugs and Medical Devices. Navigation and service. Go to: Content; Main Menu; Search; Menu. Search; DE; EN; Menu_Menu

BfArM - Companion diagnostics (CDx) - Companion …

    https://www.bfarm.de/EN/Medical-devices/Tasks/Special-topics/Companion-diagnostics/_artikel.html
    Medicines for rare diseases Pharmacovigilance Reporting risks Risk information Periodic Safety Update Reports (PSURs) Graduated plan officer Boards and Committees …

FDA – The Federal Institute for Drugs and Medical …

    https://www.fda.gov/international-programs/confidentiality-commitments/fda-federal-institute-drugs-and-medical-devices-bfarm-confidentiality-commitment
    The Federal Institute for Drugs and Medical Devices (BfArM) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) …



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