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.
You may also be interested in...
Alexion’s Soliris REMS Gets FDA Panel Review In Wider Evaluation Effort
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.
REMS Decision, Evaluation Guidances In Process, FDA Says
One draft guidance may be released this year outlining how FDA evaluates the risk-management programs.
REMS Communications Need FDA Logo To Boost Doctors’ Attention, Advisors Say
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.