U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing
  1. Regulatory Information

GUIDANCE DOCUMENT

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

Final

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

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

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.