The European Medicines Agency has finalized guidance to ensure greater consistency in the use and format of follow-up questionnaires that drug companies may be asked to develop to obtain specific information on a suspected adverse reaction as part of their routine pharmacovigilance obligations.
EMA Guide On Adverse Reaction Questionnaires Retains Challenging Requirements
When finalizing its guidance on the use of follow-up questionnaires to obtain additional information on an adverse reaction, the European Medicines Agency has addressed some of industry's concerns, but retained requirements for detailed analysis and outcome indicators.
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