Office of Medical Policy in the Center for Drug Evaluation and Research
(CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug
Administration

First published July 2018

I. INTRODUCTION

This guidance is intended to assist applicants in drafting the INDICATIONS AND USAGE section of labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products (21 CFR 201.57(c)(2)).

Recommendations include the following:

 General principles to consider when drafting the INDICATIONS AND USAGE section of the labeling

 What information to include in the INDICATIONS AND USAGE section

 When to include additional descriptors or qualifiers as part of the indication in the INDICATIONS AND USAGE section

 When to include limitations of use in the INDICATIONS AND USAGE section

 How to write, organize, and format the information within the INDICATIONS AND USAGE section

The purpose of this guidance is to help ensure that the INDICATIONS AND USAGE section is clear, concise, useful, and informative and, to the extent possible, consistent within and across drug and therapeutic classes. Applicants should follow the recommendations in this guidance when developing the INDICATIONS AND USAGE section for a new drug and when revising this section for a currently approved drug, including when seeking approval of a new indication. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Read the full guidance letter here.