1. Pink Sheet

EMA Guide On Adverse Reaction Questionnaires Retains Challenging Requirements

 
• By Vibha Sharma

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.

Hand with Side Effect word and medical equipment
Individual Case Safety Reports Often Lack Essential Info And Need To Be Followed-Up (Shutterstock)

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.

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