In March 2007, FDA issued a draft guidance entitled, Target Product Profile — A Strategic Development Process Tool. This FDA Guidance could be used to facilitate the connections between clinical planning, label statements, and scientific communications to customers. Today, several challenges exist in associating seamless integration of clinical development data into the label and then into promotional communications. This expert panel will explore ways to leverage the targeted product profile tool in your company's drug development process maximizing both the drug development and advertising/promotion regulatory expertise. The panel will also consider how to effectively incorporate the targeted product profile tool into discussions with FDA.

Learning Objectives:
Discuss scope and details of FDA Guidance: Target Product Profile — A Strategic Development Process Tool
Recognize ways that industry has developed company processes to incorporate Target Product Profile in drug development
Identify FDA considerations when reviewing Target Product Profiles with clinical plans as part of discussions with industry Discuss current challenges and potential ways to improve execution of process.