The document, entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products—Content and Format,” will apply to the Indications and Usage section for new drugs as well as new indications, or if the label of an already approved drug needs to be revised.
“The indications and usage section should clearly communicate the scope of the approved indication, including the population to which the determination of safety and effectiveness is applicable… In some cases, FDA’s expert reviewers may fairly and responsibly conclude, based on their scientific training and experience, that the available evidence supports approval of an indication that is broader or narrower in scope than the precise population studied,” the document reads.
In addition, the guidance discusses circumstances where it “may be appropriate to consider an indication for an adult population in an age group broader than the population that was studied.” This approach, however, is generally not applicable across pediatric populations or between adult and pediatric populations due to the Pediatric Research Equity Act.
The guidance is part of a series of guidances that the agency has put out or is developing in order to assist developers with the content and format of labeling for drug and biological products.
“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 in a statement. “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 healthcare providers identify appropriate treatment options for their patients.”