REMS Communications Could Get Refreshed After Advisory Panel Meeting
This article was originally published in The Pink Sheet Daily
FDA’s Risk Communications Advisory Committee will address methods for presenting REMS information and assessing whether it is reaching the target population.
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Agency will wait until it has more experience with shared REMS before deciding whether to issue regulations or guidance on their implementation, but for now it hopes sponsors can work out problems on their own.
A look at the safety record of a drug in foreign countries where REMS elements are not in play could differentiate the impact of a REMS compared to other risk management efforts, Amgen suggests.
“Before we can standardize REMS we need to have that common language to describe what’s in the REMS,” FDA’s Adam Kroetsch says.