FDA Draft Guidance on labeling for human prescription and biological products

The US Food and Drug Administration (FDA) has issued a draft guidance to provide recommendations for consideration when drafting the Indications and Usage section of human drug and biological product labeling.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.

The draft guidance, Indications and Usage Section of Labeling for Human Prescription and Biological Products’ Content and Format, describes our recommendations for how to clearly convey such information and addresses circumstances where FDA regulations require that other information, in addition to the identification of the disease or condition, be included in the Indications and Usage section.  As explained in the draft guidance, the Indications and Usage section should make clear the scope of the indication. The draft guidance describes circumstances in which an indication that is either broader or narrower than the parameters of the clinical studies supporting approval may be appropriate. The draft guidance also recommends the inclusion of age groups in the indication.

This guidance is one in a series of guidances the agency is developing or has developed to assist applicants with the content and format of labeling for human prescription drug and biological products. The labeling requirements and these guidances are intended to make information in the labeling easier for health care providers and patients to access, read and use.

FDA plans to hold a webinar about this guidance and will communicate once the date is finalized.