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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.