FDA Guidance: Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products - Considerations, Content, and Format
Date: 2014-12-10
Source: fda.gov
Abstract:
This guidance is intended to assist applicants in preparing the CLINICAL PHARMACOLOGY 18 section of product labeling to meet regulatory requirements (21 CFR 201.57(c)(13)) and ensure 19 appropriate consistency in the format and content of this section for all prescription drug 20 products approved by FDA.2 The guidance provides recommendations to applicants submitting 21 new drug applications (NDAs) (including applications submitted under section 505(b)(2) of the 22 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)), abbreviated new drug applications 23 (ANDAs), supplements to approved NDAs, biologics license applications (BLAs), and 24 supplements to BLAs, who intend to prepare or amend the clinical pharmacology information in 25 the labeling for human prescription drug or biological products. Not all of the information 26 identified in this guidance for inclusion in the CLINICAL PHARMACOLOGY section of 27 product labeling will be applicable for every drug; rather, the guidance provides a general 28 framework and set of recommendations that should be adapted to specific drugs and their 29 conditions of use. For clinical pharmacology information presented in other parts of labeling 30 (see section III.B of this guidance), applicants should consult other relevant guidances for current 31 perspectives on best labeling practices.
 |
Click here to download the file
|
|
