19.05.2016

CDER to issue 3rd Acknowledgement for Successful eCTD Submissions

Flag of USA

Beginning May 31, 2016, CDER will begin issuing an acknowledgement to FDA Electronic Submissions Gateway (ESG) users when their NDA, ANDA, BLA, IND or DMF submission has successfully completed validation and processing, and is available to the assigned review division. This acknowledgement is in addition to the ESG Message Delivery Notification acknowledgement (first acknowledgement) and the Official Center acknowledgement (second acknowledgement), and is referred to as the "third acknowledgement.

 

[Source: FDA website]

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