New Labeling Guidance Addresses Dosage and Administration
FDA issued a new guidance for industry to help new drug applicants write the dosage and administration section of their products' labels.
The US Food and Drug Administration issued a new guidance for industry, Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products-Content and Format, to help new drug applicants write the dosage and administration section of their products' label. The guidance provides recommendations about the types of information to include, the format for the section, and when to include information from other labeling sections.
In addition to basic dosing information such as the recommended starting dose and route of administration, the guidance discusses information that should be included regarding monitoring, safety modifications that need to be made because of drug interactions, and modifications required for certain patient populations such as children. The guidance calls for even more detail regarding dosage compliance. For example, the guidance states, “If it is particularly important that doses be given 8 hours apart…the section should explain the importance of 8-hour spacing of doses.”
Other components of the dosage and administration label should address premedication information and key administration instructions such as whether the drug is light-sensitive or should not be crushed or chewed.
