Providing Regulatory Submissions in Electronic Format — Content of Labeling

Issue Date: April 21, 2005
Issued by: Center for Biologics Evaluation and Research
Topic(s): Electronic Submissions,
Status: Final

Providing Regulatory Submissions in Electronic Format — Content of Labeling

This is one in a series of guidance documents intended to assist applicants making regulatory submissions to FDA in electronic format. Agency guidance documents on electronic submissions will be updated regularly to reflect the evolving nature of the technology and the experience of those using this technology.

Download the Guidance Document