Home » EMA Guidance Addresses Individual Case Safety Reports for Clinical Trials
EMA Guidance Addresses Individual Case Safety Reports for Clinical Trials
November 17, 2010
Reports of suspected unexpected serious adverse reactions (SUSARs) occurring in clinical trials in the European Economic Area will soon have to include an assessment of any drug or drugs suspected of playing a role in the event, according to final guidance by the European Medicines Agency (EMA).
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