FDA “Reminds” Doctors To Talk About Drug Benefits
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?
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FDA draft report on REMS standardization also suggests creating a patient counseling tool template for providers.
One draft guidance may be released this year outlining how FDA evaluates the risk-management programs.
Agency’s Risk Communications and Advisory Committee is holding a two-day meeting to discuss how to better target FDA communications.