This is one in a series of guidance documents intended to assist applicants when making regulatory submissions in electronic format to the Center for Biologics Evaluation and Research (CBER). CBER will update guidance documents on electronic submissions periodically to reflect evolving technology and the experience of those using this technology.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.