Guide on Clinical Pharmacology Drug Labeling

FDA has released a guidance on the “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format” that offers recommendations on preparing this section in prescription drug labeling. “Not all of the information identified in this guidance for inclusion in the Clinical Pharmacology section of labeling will be applicable for every drug; rather, the guidance provides a general framework and set of recommendations that should be adapted to specific drugs and their conditions of use,” the agency says. Examples of specific recommendations include strategies for dose selection, therapeutic individualization, and minimization of adverse reaction risk. For clinical pharmacology information presented in other parts of labeling, applicants should consult other relevant guidances for current perspectives on best labeling practices, it says.