Structured Product Labeling

Structured Product Labeling Release Four Training Sessions

Description:

A series of Structured Product Labeling (SPL) Release Four training sessions are being offered to individuals responsible for the preparation and submission of drug establishment registration and drug listing information to the FDA.

Background

The FDA Amendments Act placed into law the requirement for electronic drug establishment registration and drug listing. FDA is adopting the use of extensible markup language (XML) files in a standard SPL format as the standard format for the exchange of drug establishment registration and drug listing information. The focus of the web conferences will be the preparation of the SPL Release Four documents. The face-to-face discussion will provide more in-depth information about the preparation of the documents and the relationships of the data in each document.

Target Audience

Attendees of the web conferences and face-to-face training session should be individuals responsible for registering drug establishments and listing drug products.