The U.S. Food and Drug Administration issued a draft guidance to provide recommendations for consideration when drafting the Indications and Usage section of human drug and biological product labeling. The FDA regulations require the Indications and Usage section of drug labeling to 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.
"FDA-approved labeling is the primary communication tool for providing information on the safe and effective use of drugs to the medical community," said Jacqueline Corrigan-Curay, M.D., J.D., director of the Office of Medical Policy in FDA's Center for Drug Evaluation and Research. "This guidance provides recommendations for drafting the Indications and Usage section of the labeling, including a discussion of the scope of an indication and the inclusion of age groups in indications. We believe this guidance will help health care providers identify appropriate treatment options for their patients."
Read more: http://www.worldpharmanews.com/fda/4474-fda-takes-steps-to-encourage-more-informative-labeling-on-prescription-drug-and-biological-products-indications-and-usage