Include Only Critical Safety/Efficacy Info in Patient Counseling Labeling: FDA

September 18, 2013
Only information critical for the safe and effective use of a drug or biologic should be included in the patient counseling section of the product’s label, FDA draft guidance posted Tuesday states. The part of the label highlighting issues doctors should discuss with patients should focus on major risks of the drug and, if applicable, how the patient can mitigate or manage those risks, the guidance adds.
Drug Industry Daily