Try starting with the label

WASHINGTON - The FDA announced the start of a pilot project that is intended to help sponsors stay on a regulatory path that can ultimately lead not only to approval, but also to the indication they expect.

The Targeted Product Information (TPI) project formalizes the process of starting drug development with the end point in mind and collaborating with FDA to maximize the probability of achieving the desired goal. TPI is being conducted by FDA's Office of Drug Evaluation IV (ODE IV), which reviews anti-infective and antiviral drugs and drugs intended to treat immunologic conditions...