FDA issues draft guidance on dosage and administration labeling

Regulatory NewsRegulatory News | 13 January 2023 |  By 

The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving the consistency of information in the dosage and administration section of prescription drug labeling. Such consistency will ensure that labeling is “pertinent and understandable” to health care practitioners, said the agency.
The draft is a wholesale rewrite of an earlier guidance issued in March 2010, which has now been withdrawn. The new guidance, which is roughly triple the length of the previous one, goes into greater detail on dosage and administration information for specific drug types and addressing special populations.
The draft addresses fundamental dosage and administration-related information; dosage modifications; dosage in specific populations, including pediatric or geriatric populations, and use in patients with renal or hepatic impairment. The guidance also addresses information about switching to the subject drug from other products; provides information regarding missed doses; and addresses how to discontinue the drug. It also covers the preparation and administration of parenteral drugs and addresses storage instructions for reconstituted or diluted products.
FDA states that language in this section “should be presented in a clear, concise manner, using active voice and command language whenever possible.” Since the prescribing information is written for health care practitioners, information “should be presented in a manner that is pertinent and understandable to health care practitioners, which can help reduce medication errors.”
The guidance advises sponsors to avoid providing “distracting” information in this section, such as listing contradictions or providing efficacy data.
The most “clinically relevant” dosage and administration should appear first, such as the recommended dosage, the route of administration and instructions on use. Information on dosage modifications for drug interactions, instructions on reconstituting lyophilized powder and instructions on how to administer a solid oral dosage form with liquids or soft foods should be listed next.
The dosage information should include an upper dosage range, or the limit beyond which safety and effectiveness have not been established. It should also list the dosages for each indication and subpopulation, address the intervals recommended between doses, and describe the optimal method for titrating dosages.
For parenteral drugs, specific containers or devices that are needed for dose administration should be included in the labeling. Labeling should indicate the risk of manipulating different dosage forms, such as modified-release drugs. For example, if there is a risk associated with manipulating modified release tablets, the labeling should indicate that tablets should be swallowed whole and should not be split or crushed.
Applicants should also avoid using certain abbreviations such as “QD” because this term can be misread as Q1D; it is preferable instead to use the phrase “once daily.”
The agency recommends that sponsors consult its July 2022 guidance for addressing more complicated or detailed patient-use instructions. (RELATED: Dose banding: FDA aims to reduce drug waste in new labeling guidance, Regulatory Focus 20 July 2022).
FDA will be accepting comments until 14 March. Comments should be submitted to FDA-2007-D-0201-0006.
Draft guidance


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Tags: FDA, labeling

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