US FDA Guidance On Patient Labeling Leaves Unanswered Questions For Combination Products

The US Food and Drug Administration’s final guidance on patient instructions for use of drug and biological products does not include details sought by industry, including clarity on the identification of drug products with multiple parts and the human factors that may impact instructions. The document will also apply to combination products the include devices but are regulated as drugs or biologics. 

The guidance, “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format,” provides recommendations for developing instructions on how to use prescription...