Guidance for Industry Providing Regulatory Submissions in Electronic Format – Drug Establishment Reg

• Date: November 30, 2009
• Source: www.fda.gov

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. The guidance and accompanying technical documents explain (among other things): • The statutory requirement to submit electronically drug establishment registration and drug listing information; • How to create a Structured Product Labeling (SPL)2 file for submitting drug establishment registration and drug listing information to FDA through the Electronic Submissions Gateway (ESG) using defined code sets and codes, i.e., a language recognized by the computer system; and • Beginning June 1, 2009, FDA intends to no longer accept drug establishment registration and drug listing information in paper format unless a waiver is granted. FDA intends to update these documents regularly to reflect the evolving technology and user experience.

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