Proposed Info Collection on Target Product Profile Guide

Federal Register notice: FDA has submitted to OMB a new proposed information collection supporting its “Draft Guidance for Industry and Review Staff on Target Product Profile — A Strategic Development Process Tool.” Target product profiles (TPPs) can be prepared by a sponsor and then shared voluntarily with the appropriate FDA review staff to facilitate communication on a particular drug development program. They are based on a template that provides a summary of drug labeling concepts to focus discussions and aid in the understanding between sponsors and FDA. With the TPP, a sponsor specifies the labeling concepts that are the goals of the drug development program, documents the specific studies that are intended to support the labeling concepts, and then uses the TPP to assist in a constructive dialog with FDA. The draft guidance describes the purpose of a TPP, its advantages, and its optimal use. To view the notice, click here.