FDA Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format

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Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format[附网盘链接]是Food And Drug Administration于当前发布的FDA标准，适用于United States。

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Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not create any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA offices responsible for this guidance as listed on the title page. I. INTRODUCTION 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 2,3

prescription drugs approved by FDA. 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. For clinical pharmacology information presented in other parts of labeling (see section III.B of this 1

This guidance has been prepared by the Office of Clinical Pharmacology, Office of Translational Sciences in cooperation with the Labeling Development Team, Office of New Drugs, in the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). 2

This document provides guidance on the CLINICAL PHARMACOLOGY section of prescription drug labeling (21 CFR 201.57(c)(13)) under the 2006 final rule that amended the requirements for the content and format of labeling for human prescription drug and biological products (commonly referred to as the Physician Labeling Rule (PLR)). See Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products (71 FR 3922, January 24, 2006). 3

This guidance applies to drugs, including biological products that are regulated as drugs. For the purposes of this guidance, “drug product” or “drug” will be used to refer to human prescription drug and biological products that are regulated as drugs.

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