FDA Publishes Guidance on Labeling Drugs and Biological Products

FDA published a guidance document on Jan. 16, 2023 intended to assist applicants in developing the Dosage and Administration section of labeling as described in 21 Code of Federal Regulations 201.57, a regulation governing the content and format of the section of human prescription drug and biological product labeling. The applicants should follow the recommendations in the new guidance when developing the Dosage and Administration section for a new drug submitted to FDA under a new drug application under section 505(b) of the Food, Drug, and Cosmetic Act or a biologics license application under section 351(a) of the Public Health Service Act.

The guidance provides examples of required and recommended information in the Dosage and Administration section.

Source: FDA