While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of prescription drug labeling is significantly larger than an earlier guidance issued in 2010, industry stakeholders said they wanted more information from the agency on how labeling of specific cases should be handled.
FDA’s draft guidance on improving development of the dosage and administration section of drug labeling is written to inform industry on required and recommended information that is “particularly critical to the safe and effective use of the drug,” such as the dosage range, starting or loading dose, dosage, titration schedule, maximum recommended dosage and duration, effectiveness, and concomitant therapy information, the agency said. (RELATED: FDA issues draft guidance on dosage and administration labeling, Regulatory Focus 13 January 2023)…
