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USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling

Recently on 12-January-2023, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format”.

As part of this guidance, applicants are urged to ensure that the DOSAGE AND ADMINISTRATION section contains all the dosage and administration-related information needed for safe and effective drug administration, is clear and concise, and is presented in a manner that health care practitioners can understand.


Applicants should review this section at least annually to ensure that this section contains accurate, clear, and up-to-date information. Information that would ordinarily be required in this section may be omitted if the information is clearly inapplicable.


It is important to organize and present information in the DOSAGE AND ADMINISTRATION section in a way that promotes understanding and readability.


Depending on the amount and type of information in this section, many different organizational schemes may be adequate to ensure readability and comprehension.


The sequence of dosage and administration-related information in this section should be based on its relative clinical importance.


The most clinically relevant dosage and administration related information should generally appear first and Other types of dosage and administration-related information should generally appear later in the section.


Click this LINK to see the examples of required and recommended information in the DOSAGE AND ADMINISTRATION section.


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