The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and biological product labeling as well as how drug interaction information should appear in other areas of the product’s labeling.
FDA said the goal of the guidance is offer recommendations to applicants on how to write drug interaction content for labeling on these products and “to enhance communication of clinically significant drug interactions and facilitate the safe and effective use of prescription drugs by healthcare practitioners.”…
