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EU Clinical Trials Delayed By Poor Reference Safety Information

 
• By Vibha Sharma

EU regulators are increasingly raising objections over the reference safety information that companies include in their clinical trial applications and updated investigator's brochures.

A number of clinical trials sponsored by the innovative pharmaceutical industry have experienced delay in the EU because of companies failing to satisfy the expectations regulators have with regard to the reference safety information (RSI) submitted in clinical trial applications and as updates to investigator brochures.

Regulators are increasingly focusing on the RSI in submissions and are raising a number of questions and objections on this...

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