FDA Issues New Guidance on Assessing REMS

The FDA released two draft guidances outlining the agency’s latest thinking on assessments of risk evaluation and mitigation strategy (REMS) programs.

One guidance deals with REMS assessment plans and advises sponsors to include process metrics, such as how many patients are enrolled, as well as outcomes measures, such as how many fetal exposures are prevented.

Sponsors can use postmarket adverse event data, drug use data, and observational or epidemiological data, in addition to stakeholder input for their REMS assessments, the agency said.