Draft Revision on Drug eSubmissions Guide

FDA has posted a draft guidance as its seventh revision to “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The document describes how sponsors and applicants must organize the content that they submit to the agency electronically for all submission types. It also references several technical specification documents and the Electronic Common Technical Document Conformance (eCTD) Guide, which provide additional details regarding the organization of content for electronic submissions. FDA says that this revision modifies previous versions by including exemptions for Type III drug master files. In addition, it includes criteria identifying those types of submissions that may qualify for a long-term or a short-term waiver from the eCTD submission requirement and instructions on how to submit a waiver request.