FDA Drafts Guidance on Target Product Profiles and Issues 2007 Agenda

In March, the US Food and Drug Administration released a new draft guidance, along with its guidance agenda for the year. The draft, “Guidance for Industry and Review Staff: Target Product Profile-A Strategic Development Process Tool,” is designed to provide sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) with information regarding target product profiles (TPPs).

A TPP is a format for a summary of a drug development program 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. The guidance describes the purpose of a TPP, its advantages, and its optimal use. It also provides guidance on how to complete a TPP and relates case studies that demonstrate a TPP’s usefulness.

The guidance has been prepared by the Office of New Drugs in CDER and is open for comment. This draft guidance, when finalized, will represent the FDA’s current thinking on this topic.

CDER has also released its guidance agenda for the year 2007. The plan includes a guidance on quality by design and the long-awaited guidance for process validation, which would update the 1987 process validation guidelines. The complete agenda can be found at: http://www.fda.gov/cder/guidance/CY07.pdf.