FDA Issues Guidance on 'Patient Counseling Information' in Drug Labeling
The Food and Drug Administration on Dec. 9 issued new guidance on the labeling of prescription drug and biological products. In “Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format” (here), FDA provides guidance…
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on how to decide what topics to include in the patient counseling information section, as well as how to present information and organize the section, it said.