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# CBER Post New E-Submission Frequently Asked Questions Guide
- URL: https://www.fdaweb.com/cber-post-new-e-submission-frequently-asked-questions-guide/
- Published: 2026-06-01T12:00:00.000Z
- Updated: 2026-09-14T13:40:17.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161231

FDA has issued a new set of [frequently asked questions ](https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/frequently-asked-questions-faqs-electronic-submissions-program-cber-regulated-products?ref=fdaweb.com)(FAQ) aimed at helping companies navigate the electronic submission process for products regulated by CBER, offering additional guidance on technical requirements, acknowledgment timelines, and common causes of submission rejections.

The FAQ document addresses recurring issues encountered by sponsors submitting biologics applications, investigational new drug applications, drug master files and other regulatory filings through the agency’s Electronic Submissions Gateway NextGen (ESG NG).

Among the clarifications, FDA said sponsors should allow up to 24 hours to receive a third acknowledgment notice, known as ACK 3, after submitting an application. Delays can result from high submission volumes, manual reviews or technical issues. The agency also outlined common reasons for technical rejection notices, including significant electronic Common Technical Document (eCTD) validation errors, incorrect submission formats, corrupted files and missing supplement numbers on required FDA forms.

The agency reiterated that submissions received on weekends or federal holidays are considered received on the next business day and noted that the ACK 3 date may differ from the original submission date because it reflects when the filing was processed into CBER's repository.

FDA also emphasized that all documents associated with a non-eCTD submission must be submitted together under a single ESG core ID number. Separate document uploads can create multiple core IDs and will not be consolidated by the agency for review.

The guidance confirms that CBER does not generate acknowledgments for non-eCTD submissions and does not support hyperlinks between separate applications under review. Video files submitted in eCTD format generally should be placed in Module 1.15 for promotional materials.

In addition, the document provides contact information for sponsors seeking assistance with submission validation, account setup, regulatory review questions and study data submissions, and outlines procedures for requesting eCTD waivers for certain positron emission tomography and Type II drug master file submissions.

The FAQ is intended to streamline the submission process and reduce technical deficiencies that can delay regulatory review of biologics and related products.