- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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:
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.