
FDA Issues Draft Guidance on Patient Counseling Info for Labeling
FDA Issues Draft Guidance on Patient Counseling Info for Labeling
FDA has released its draft guidance,
A final rule amending requirements for the content and formatting of labeling, published on Jan. 24, 2006, created the new required section, Patient Counseling Information (§ 201.57(c)(18)). The section summarizes the information that a healthcare provider should convey to a patient. According to the draft guidance, patient-counseling information must contain information necessary for patients to use the drug safely and effectively and, if applicable, reference to FDA-approved patient labeling.
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