FDA REMS Platform Will Make Safety Plans Easy – Maybe Too Easy?
This article was originally published in The Pink Sheet Daily
There is concern that common software package could mean more drugs end up with risk management programs.
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FDA hopes to begin accepting Risk Evaluation and Mitigation Strategy documents in structured product labeling format later this year.
Data may help industry stake out its negotiating position as formal talks near for user fee reauthorization.
FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.