FDA encourages more informative labeling on prescription drug and biological products' indications and usage
FDA has issued draft guidance featuring recommendations to consider when drafting the Indications and Usage section of human drug and biological product labeling.
FDA has issued draft guidance featuring recommendations to consider when drafting the Indications and Usage section of human drug and biological product labeling. According to FDA, that section of drug labeling must state that the drug is indicated for the treatment, prevention, mitigation, cure or diagnosis of a disease or condition, or for the relief of the disease or condition's symptoms. The draft guidance describes the agency's recommendations on how to clearly convey such information and addresses situations in which FDA regulations require that other information, in addition to the identification of the disease or condition, be included in the Indications and Usage section. Noting that "FDA-approved labeling is the primary communication tool for providing information on the safe and effective use of drugs to the medical community," Jacqueline Corrigan-Curay, MD, JD, director of the Office of Medical Policy in FDA's Center for Drug Evaluation and Research, said the draft guidance includes "a discussion of the scope of an indication and the inclusion of age groups in indications." The draft guidance is available <a href="https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma…; target="_blank">here</a>.