REMS Decision, Evaluation Guidances In Process, FDA Says
This article was originally published in The Pink Sheet Daily
One draft guidance may be released this year outlining how FDA evaluates the risk-management programs.
You may also be interested in...
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.
Proposed pilot program would look for the best patient counseling practices, but can FDA remind providers to discuss a drug’s benefits without actually specifying them?
Agency will wait until it has more experience with shared REMS before deciding whether to issue regulations or guidance on their implementation, but for now it hopes sponsors can work out problems on their own.