Current Status of Computer-Assisted NDAS

Abstract

The Center for Drugs and Biologics (CDB)-FDA is currently involved in a number of experiments involving computer-assisted new drug applications (NDAs). These experiments vary from an electronic mail box “question—answer” system to a double cross-over review involving clinical data files structured by a third party firm. CDB will present analysis as to the types of problems encountered by both CDB and participating firms, the impact to date of a computer-assisted NDA on the review process itself, where CDB is heading with this overall concept and what the future might hold in store for both industry and CDB relative to future computer assisted submissions.