cber submissions

New 3rd Acknowledgement for CBER Submissions

3rd Acknowledgement indicates if your submission has pass preliminary validation or notes any errors that occurred during validation

3rd Acknowledgement indicates if your submission has pass preliminary validation or notes any errors that occurred during validation
August 29, 2018
Since May 2016 when an eCTD sequence is sent to the Center for Drugs Evaluation and Research (CDER) via the Electronic Submissions Gateway (ESG) an acknowledgement of receipt is received with the results of the validation.
ESG has recently announced that this acknowledgement will also be received for all submissions sent to the Center for Biologics Evaluation and Research (CBER) beginning September 4, 2018. 
Known as 3rd Acknowledgement, it will be in PDF format and will be sent to you when your submission has successfully completed validation and processing, and is available to the assigned review division. This is in addition to the ESG Message Delivery Notification acknowledgement (first acknowledgement) and the Official Center acknowledgement (second acknowledgement). A rejection is also a third acknowledgement
Asphalion has extensive experience in FDA Submissions. Contact us for US regulatory support at fda@asphalion.com
 

Search News & Events

  • Filter by category

Share

Related news and events

Christmas season greatings

Season’s Greetings

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting