New Draft Guidance

U.S. FDA Issues “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format” Draft Guidance for Comment


January 2023—The U.S. Food and Drug Administration has issued draft guidance for comment purposes. The guidance includes non-binding recommendations and is accepting comments through 3/14/2023. The document titled: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format has been made available to assist in the development of the DOSAGE AND ADMINISTRATION section of labeling.


Stay tuned for our blog post detailing the guidance in a comprehensive breakdown and weighing in on some implications the revision to the guidance issued March 29, 2010.

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