Electronic submissions to FDA
This article was originally published in The Tan Sheet
Executive Summary
"Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations" and "Guidance for Industry: Providing Regulatory Submissions in Electronic Format - NDAs" issued by FDA Jan 27. The agency "has decided to develop one guidance on those topics common to all submission types and to create individual guidances on specific submission types." Comments on either document will be accepted at any time