Description
The purpose of this document is to provide guidance to industry on the implementation of the label process changes described in the companion document LPS2003-01, Label Process Changes Part 1: Overview. This document provides direction to applicants concerning label requirements and process for new submissions and submissions in progress.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Label Process Changes: Part 2: Guidance for Industry | HTML | Open resource | |
| Label Process Changes: Part 2: Guidance for Industry | HTML | Open resource |