Draft Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." This draft guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear and accessible and complying with the new requirements in the final rule on the content and format of labeling for prescription drug and biological products (71 FR 3922, January 24, 2006). This draft guidance is intended to help applicants select information for inclusion in the "Dosage and Administration" section of labeling and to help them organize that information.