Activity Description

Welcome to the Food and Drug Administration, Center for Drug Evaluation and Research's educational activity entitled, "An Introduction to the Improved FDA Prescription Drug Labeling." This activity is designed to give you a better understanding of the revised prescription drug labeling, the format changes that were made, and why they were necessary. You will also learn about other labeling initiatives that have brought the FDA into the 21st century of promoting and protecting the health of the American people. The goal of this activity is to make information about the revised labeling clearer and more easily understood.

Learning Objectives

Upon completion of this activity, the participant will be able to:

• Describe prescription drug labeling and related FDA requirements.
• Describe the history of the drug labeling initiative.
• Describe the staged implementation schedule for the revised prescription drug labeling.
• Describe the major content and format changes to prescription drug labeling and the rationale for the changes.
• Describe other related FDA electronic labeling initiatives.

 General Instructions (Plugins, Audio)

Plugins - If you do not currently have the Adobe Flash Player and/or the Adobe Reader installed on your computer, you can click the appropriate link to launch the download page in a new window.

• Open the Adobe Flash Player Download Page (Required to View Flash Course)
• Open the Adobe PDF Reader Download Page (Required to View PDF Documents)

Audio - Before entering the activity, turn on your computer's speakers.

 Updated Links Within Course

• Facts@FDA
• New Requirements for Prescribing Information