REMS Need Metrics For Assessing Success, Burden On Health Care System
“We don’t really have clear methods for assessing burden and access,” CDER’s Mary Willy acknowledges. A lack of baseline information hinders the measurement of whether REMS and their components are working.
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FDA advisory committee will revisit REMS for ultra-rare disease drug as part of larger agency effort to evaluate the effectiveness of the safety programs.
One draft guidance may be released this year outlining how FDA evaluates the risk-management programs.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.