2023 FDA Labeling Draft Guidence

Jan 24, 2023

New Draft Guidance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and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format” Draft Guidance for Comment

January 2023—The U.S. Food and Drug Administration has issued draft guidance for comment purposes.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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Let's work together!

We’re always looking for new opportunities. If you would like to partner with us, please get in touch.

Let's work together!

We’re always looking for new opportunities. If you would like to partner with us, please get in touch.