logo BDSP

Base documentaire


  1. Limitations and strengths of spontaneous reports data.

    Article - En anglais

    US Food and Drug Administration (FDA) monitoring of the continued safety of marketed medical products depends greatly on spontaneous reporting of serious adverse events by health professionals.

    Despite its inherent limitations, the national postmarketing surveillance system provides vital information of clinical importance.

    Mots-clés Pascal : Food and Drug Administration, Organisme réglementation, Etats Unis, Amérique du Nord, Amérique, Pharmacovigilance, Médicament, Toxicité, Diagnostic, Qualité, Collecte donnée, Déclaration

    Mots-clés Pascal anglais : Food and Drug Administration, Regulatory institution, United States, North America, America, Pharmacovigilance, Drug, Toxicity, Diagnosis, Quality, Data gathering

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 99-0125810

    Code Inist : 002B30A08. Création : 16/11/1999.