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GUIDANCE DOCUMENT

Providing Regulatory Submissions in Electronic Format--Receipt Date February 2014

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs

This is one in a series of guidance documents intended to assist sponsors, applicants, and others making regulatory submissions to the Food and Drug Administration (FDA) in electronic format.

Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.