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GUIDANCE DOCUMENT

Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing May 2009

Final
Docket Number:
FDA-2005-N-0464
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: FDA-2005-N-0464.