Jan 13 -- The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” This guidance is intended to assist applicants in developing the DOSAGE AND ADMINISTRATION section of labeling. The purpose of this guidance is to assist applicants in ensuring that the DOSAGE AND ADMINISTRATION section contains the dosage- and administration-related information needed for safe and effective use of a drug and that the information is clear, concise, and presented in a manner that is pertinent and understandable to health care practitioners. We are withdrawing the guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format” issued on March 29, 2010, and issuing this draft guidance.
Submit either electronic or written comments on the draft guidance by March 14, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
FDA is announcing the availability of a draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” FDA is also withdrawing its previous guidance for industry, issued on March 23, 2010 (75 FR 13766), which was entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.”
The draft guidance, when finalized, is intended to assist applicants in developing the DOSAGE AND ADMINISTRATION section of labeling to ensure that this section contains the dosage- and administration-related information needed for safe and effective use of a drug and that the information is clear, concise, and presented in a manner that is pertinent and understandable to health care practitioners. Applicants should follow the recommendations in this guidance when developing this section for a new drug submitted to FDA under a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act or a biologics license application under section 351(a) of the Public Health Service Act, and when revising existing information in the labeling for a currently approved drug in a supplement to such applications.
This draft guidance provides examples of required and recommended information in the DOSAGE AND ADMINISTRATION section. This guidance provides recommendations on including certain dosage- and administration-related information in the DOSAGE AND ADMINISTRATION section that is particularly critical to the safe and effective use of the drug (e.g., lack of knowledge of the information or nonadherence to a recommendation could have serious consequences for patients).
This draft guidance addresses the dosage and route of administration for each indication in the DOSAGE AND ADMINISTRATION section and information about the dosage range, the starting or loading dose and dosage, titration schedule, the maximum recommended dosage, the maximum recommended duration, monitoring for effectiveness, and concomitant therapy information in the DOSAGE AND ADMINISTRATION section, as appropriate.
This draft guidance also addresses the following information in the DOSAGE AND ADMINISTRATION section:
• Other drugs used before, during, or after drug treatment or administration;
• Dosage modifications for adverse reactions or for drug interactions;
• Dosage in specific populations (e.g., pediatric patients, geriatric patients, patients with renal impairment, patients with hepatic impairment);
• Information about switching to the subject drug from other products or substitution involving the subject drug;
• Recommendations regarding missed dose(s);
• Recommendations in event of vomiting after oral drug administration;
• Recommendations for drug discontinuation or dosage reduction when there are risks of withdrawal; and
• The recommended dosage for fixed-combination drug products and co-packaged products.
Furthermore, this draft guidance addresses when and how to include information in the DOSAGE AND ADMINISTRATION section on the preparation and/or administration of the drug (e.g., parenteral products, a product stored in the refrigerator or freezer, pharmacy bulk packages, imaging bulk packages, solid oral dosage forms with qualified liquids or soft foods, oral dosage forms via enteral feeding tubes, liposome drug products); instructions to avoid harm related to drug handling and administration, radiation dosimetry; and information on drug incompatibilities if the drug is mixed with other drugs. This guidance also provides information on storage instructions for the reconstituted or diluted product.
Finally, this draft guidance describes information that should ordinarily not be included in the DOSAGE AND ADMINISTRATION section.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Draft guidance:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dosage-and-administration-section-labeling-human-prescription-drug-and-biological-products-content
FRN:
https://www.federalregister.gov/d/2023-00619