REMS And Benefits? FDA, Industry Debate Moving Beyond Safety Information
Included in FDA's upcoming look at improving Risk Evaluation and Mitigation Strategies may be an adjustment to Medication Guides to include drug benefits alongside risks
You may also be interested in...
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?
The single-page format could serve as a template as FDA tries to simplify patient information that accompanies prescription drugs.
OND Director Jenkins notes that risk management plans should be interoperable, but will not be identical.