chapter  3
6 Pages

Data Presentation for Global Submissions: Text and Tabular Exposition—CTD Format

ByPatricia Blaine

INTRODUCTION Over the years, representatives of both the regulatory agencies and the pharmaceutical industry have published in pharmaceutical journals or presented at workshops many helpful suggestions to facilitate regulatory review of the Common Technical Document (CTD) or other submissions and to avoid elements that impede the review. Several authors and presenters have expressed reviewers’ frustration at having to review a submission that is incoherently assembled or confusing in its presentation.