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GUIDANCE DOCUMENT

Target Product Profile -- A Strategic Development Process Tool March 2007

Draft

Not for implementation. Contains non-binding recommendations.

Target Product Profile -- A Strategic Development Process Tool

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to provide sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) with information regarding target product profiles (TPPs). A TPP is a format for a summary of a drug development program2 described in terms of labeling concepts. A TPP can be prepared by a sponsor and then shared with the appropriate FDA review staff to facilitate communication regarding a particular drug development program. Submission of a TPP is voluntary.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.