New Document Includes Labeling Guidelines for Dosage, Administration, and Safety

April 5, 2010 2:06 pm

A new guidance document, Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format, was released by FDA and includes recommendations to help new drug applicants write the dosage and administration section of product labeling. The guidance provides recommendations about the types of information to include, the organizational format, and when to include information from other labeling sections. The document also advises including information on safety monitoring procedures, dosage modifications due to drug interactions and for specific patient populations, and the importance of dosage regimen compliance, if applicable. The guidance was developed to help ensure that dosage and administration information included in labeling is clear and accessible, and that it will aid in safe and effective dosing.