Providing Regulatory Submissions in Electronic Format; General Considerations

Issue Date: January 28, 1999
Issued by: Center for Drug Evaluation and Research
Topic(s): Electronic Submissions,
Status: Final

Providing Regulatory Submissions in Electronic Format; General Considerations

This is one in a series of guidance documents intended to assist you when making regulatory submissions in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). This guidance discusses general issues common to all types of electronic regulatory submissions. In some cases, the guidance for one center differs from that for the other center because of differences in procedures and in the computer infrastructures in the centers. We will work to minimize these differences wherever possible.

Download the Guidance Document