FDA urged to expand on integrated review

A new FDA drug review template, part of an integrated review system unveiled in June, is raising concerns that data that would be valuable for drug development and for informing treatment decisions could be left on the cutting room floor.

FDA's integrated review shifts the agency's NDA and BLA review process to a more team-based approach. In addition, rather than publishing a compilation of each discipline’s review, the new review document would be formatted as a summary document based on the multidisciplinary review (see “FDA Revamps Review Process”)...