iPLEDGE Again On FDA Advisory Agenda, This Time As An Example
This article was originally published in The Pink Sheet Daily
"REMS-related topics" is the theme of a joint FDA advisory committee meeting Dec. 1 focused on the landmark iPLEDGE program as an example of the effect such programs have on the health care system.
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“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.
Among other timetables set as part of the broad deal with industry, FDA will host meetings and issue guidances to assess and minimize the burden of REMS on the practitioners and patients.
FDA's decision to create a class Risk Evaluation and Mitigation Strategy for all transmucosal fentanyl products indicates that the agency could take a similar strategy with the extended-release opioids.