FDA Plans Updates to Prescription Drug Labels


The U.S. Food and Drug Administration (FDA) plans to make changes to the indications and usage section of drug and biological product labels.

According to FDA regulations, this section on drug labels must state that the medication is indicated to treat, prevent, mitigate, cure, or diagnose a disease or condition; or to relieve symptoms of a disease or condition. The proposed guidelines recommend the inclusion of age groups in this section and outline the FDA’s recommendations for conveying information clearly. They also address specific circumstances in which FDA regulations require additional information, such as when an indication is broader or narrower than the clinical studies supporting the drug’s approval.

When finalized and approved, these updated guidelines will make drug labels easier to read and use for health care providers and patients, according to the FDA.

Sourced from: FDA