This guidance is intended to assist applicants in preparing the CLINICAL PHARMACOLOGY section of prescription drug labeling (henceforth referred to as labeling) to meet regulatory requirements and ensure appropriate consistency in the format and content of this section for all prescription drugs approved by FDA.2,3 The guidance provides recommendations to applicants submitting new drug applications (NDAs) (including applications submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)), abbreviated new drug applications (ANDAs), supplements to approved NDAs, biologics license applications (BLAs), and supplements to BLAs, who intend to prepare or amend the clinical pharmacology information in the labeling for human prescription drugs. 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.





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