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# Target Product Profile Benefits Education Needed: CDER
- URL: https://www.fdaweb.com/target-product-profile-benefits-education-needed-cder/
- Published: 2017-04-19T12:00:00.000Z
- Updated: 2026-09-14T22:18:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138480

Three CDER staffers say that drugs and biologics approved by FDA that mention target product profiles (TPPs) are associated with more efficient regulatory review times, perhaps because of increased planning or because the TPP promotes well-organized regulatory dialog. Writing in *CellPress*, the three [say](http://www.cell.com/trends/biotechnology/pdf/S0167-7799%2817%2930035-5.pdf?ref=fdaweb.com) that TPPs are used as a regulatory tool for dialog on clinical development or manufacturing plans.

The difference in regulatory review times seems to suggest a beneficial role of TPPs as a means of focusing discussion on labeling claims or potential manufacturing issues, the article says.

They point out that TPPs are used infrequently and late in the development process. “We suggest that increased education about the benefits of this regulatory communication tool may promote more frequent and appropriate use of TPPs with the aim of shortening the entire development cycle and using development and regulatory resources more efficiently and effectively,” the authors say.