REMS Enhancements Could Include Provider Education Credits
This article was originally published in The Pink Sheet Daily
FDA draft report on REMS standardization also suggests creating a patient counseling tool template for providers.
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?
“Before we can standardize REMS we need to have that common language to describe what’s in the REMS,” FDA’s Adam Kroetsch says.