ODE IV Pilot
Targeted Product Information

After a 12-month collaborative effort between FDA and the Pharmaceutical Research Manufacturers Association (PhRMA), FDA’s Office of Drug Evaluation IV (ODE IV) is starting a pilot test of a tool that may improve the drug development process.  This tool is the Targeted Product Information (TPI) Document.

The TPI is an evolving version of the proposed product labeling.   It can be used by a sponsor:  1) to guide the design, conduct, and analysis of clinical trials;   2) to facilitate communication between the FDA and pharmaceutical companies; and 3) to promote a shared understanding of a sponsor’s drug development program.

This web site provides all of the information that you will need, including:

1.   Overview (Updated 11/14/2000)

• Background Information
• Intent of the Targeted Product Information Document
• What the Targeted Product Information Document IS
• What the Targeted Product Information Document IS NOT
• Summary

2. TPI Template

• HTML
• Acrobat
• Word
• WordPerfect 6.0

The TPI  is simple, easy, dynamic and voluntary.

After some experience has been gained in this pilot program, FDA/ODE IV and PhRMA will evaluate the results and determine whether to recommend the use of the TPI by other Offices and Centers within FDA.