Electronic Regulatory Submissions

Abstract

This document represents the Agency's current thinking on regulatory submissions in electronic format. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An elective methodology might be utilized assuming such methodology fulfils the necessities of the material resolution, guidelines, or both. This is one in a progression of direction records expected to help you while making administrative entries in electronic organization to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). This direction talks about broad issues normal to a wide range of electronic administrative entries. Now and again, the direction for one focus varies from that for the other focus due to contrasts in systems and in the PC frameworks in the focuses. We will attempt to limit these distinctions at every possible opportunity. Organization direction archives on electronic administrative entries will be refreshed routinely to mirror the developing idea of the innovation in question and the experience of those utilizing this innovation.