What's a TPP?

Ideally, the TPP provides a statement of the overall intent of the drug development program, and gives information about the drug at a particular snapshot in time.

Managing Your Target Product Profile

The TPP is a dynamic summary that changes as knowledge of the drug increases from preclinical and clinical studies. The TPP is organized according to the key sections outlined in the draft guidance and it links drug development activities to specific concepts intended for inclusion in labeling of the drug product. The TPP should be updated periodically as more information is gathered about the behavior of the drug product and these updated versions should be used in discussions with FDA review staff to identify the most important development goals for the drug. Often, the TPP is managed as a Word document with multiple revisions without a mechanism to link TPP elements to the quality attributes of the drug product. QbDVision provides tools specifically for managing the evolution of the TPP as well as linking these patient requirements to product requirements.

Additional Resources

You can get more information about Target Product Profiles from the FDA TPP guidance . The FDA Small Business and Industry Assistance (SBIA) Webinar Series is also hosting a webinar specifically on the Indications and Usage section of the TPP.