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Guidance on Drug, Biologic Dosage and Administration

03/23/2010

Federal Register Notice: FDA is making available a guidance, Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format. It is one of a series of guidances intended to help applicants in drafting prescription drug labeling with clear and accessible prescribing information and in complying with the requirements in the final rule on the content and format of labeling for prescription drug and biological products. It is also intended to help applicants select information for inclusion in the “Dosage and Administration” section of labeling. To download this guidance, click here. To view this notice, click here.

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