Providing Regulatory Submissions in Electronic Format - Receipt Dates

• By: Staff Editor
• Date: November 29, 2016
• Source: http://www.fda.gov/

Providing Regulatory Submissions in Electronic Format — Receipt Dates

This FDA guidance document is intended to aid sponsors, applicants and others making regulatory submissions to FDA in electronic format. The guidance details how FDA will allocate receipt dates to regulatory submissions to the CDER and CBER for drug products.

Applicability

The guidance applies to the following submissions types:

• Investigational new drug applications (INDs)
• Premarket approval applications for drugs, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and amendments and supplements to these applications
• Master files (MFs)
• Post approval studies
• Submissions related to products marketed without an approved application
• Adverse event reports
• Original submissions, amendments, supplements, post market reports, and all other regulatory submissions to these applications.

This guidance is not restricted to those submissions made using the electronic common technical document format. It applies to all these mentioned submission types if they contain information in either electronic or paper format, including hybrid submissions.

Areas Addressed in the Guidance

The guidance details the requirements for the following areas:

• Regulatory distinction between Submission and Receipt
• Decisions to receive or file an application for review
• When reporting deadlines are established in terms of calendar days
• Technical deficiencies that may stop FDA from processing, reviewing, and archiving the submission
• Examples for determining receipt date for all electronic submissions including hybrid submissions.

Related Training:

How to Transition from Paper to Electronic Records in a Regulatory Environment