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Real-World Evidence Can Play Important Role In OTC Regulation – AESGP Study

 
• By Tom Gallen

A published article from AESGP argues for the increased acceptability, application and use of real-world evidence in the OTC sector where it “may present a more intuitive or efficient way of generating data” compared to randomized controlled trials.

Real world data
• Source: Shutterstock

Rx-to-OTC switch and post-marketing safety are two key stages in the life cycle of non-prescription medicines where real-world evidence (RWE) has the potential to benefit regulatory decision making, according to a review article from the Association of the European Self-Care Industry, AESGP.

Published in the Clinical and Translational Science journal, the article “How can real-world evidence aid decision making during the life cycle of non-prescription medicines?” argues for the increased acceptability, application...

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