How To Speak REMS: Structured Product Labeling Seen As Route To Standardization
“Before we can standardize REMS we need to have that common language to describe what’s in the REMS,” FDA’s Adam Kroetsch says.
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FDA draft report on REMS standardization also suggests creating a patient counseling tool template for providers.
One draft guidance may be released this year outlining how FDA evaluates the risk-management programs.
Risk Communication Advisory Committee suggests that adding the agency imprimatur to REMS materials may help distinguish it from promotional mail and ensure providers read the communications.