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 [email protected]
