Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing

Issue Date: June 1, 2009
Issued by: Center for Drug Evaluation and Research
Topic(s): Electronic Submissions,
Status: Final

Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing

This is one in a series of guidance documents intended to assist persons making regulatory submissions to FDA in electronic format. This guidance is designed to assist manufacturers with electronic submissions of drug establishment registration and drug listing information.

Download the Guidance Document