FDA has two primary goals in its overhaul of the NDA process. The first is to find the show-stopping issues sooner and put that information in sponsor’s hands. The second is to create more time to discuss labeling and post-marketing requirements with them.
How it does that is via an internal reorganization of the process and a new review template.
The move is part of an ongoing initiative within the agency’s Office of New Drugs to increase the efficiency and consistency of the drug approval process (see “Getting Flatter”).
Comments on both the review process and template are due August 26.
Under the new process, reviewers will form multisciplinary teams that converge on the most critical issues in an application up front, rather than conducting independent