New 3rd Acknowledgement for ESG Users

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Beginning September 4, 2018,  Electronic Submission Gateway (ESG) users will receive a new 3rd Acknowledgement for all submissions sent to the Center for Biologics Evaluation and Research (CBER) in eCTD format. This 3rd Acknowledgement is similar to the one the Center for Drug Evaluation and Research (CDER) has been providing, and will be in PDF format and will contain initial validation results. This new Acknowledgement will let users know that their submission was successfully processed into the CBER Electronic Document Room and is available to the assigned review office. It will also note the Application Type/Number, eCTD Sequence Number, Core ID, and who to contact at FDA with technical questions.

AS2 ESG users must configure their AS2 software to allow for PDF acknowledgements. WebTrader users will not have to take any action to receive 3rd Acknowledgements. Since the 3rd Acknowledgement is a PDF, WebTrader users will have to download the Acknowledgement prior to viewing.

For more information on ESG accounts, see our post: Creating an ESG Account: Tips for Success.

The eCTD Summit is presented by Synchrogenix, A Certara Company.

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Author: Rob Labriola

Rob Labriola has 20 plus years experience in regulatory operations for the pharmaceutical industry. Mr. Labriola has seen it all and truly understands the frustrations and rewards of moving to eCTD. He has worked on multiple application types (INDs, NDAs, BLAs, CTAs, NDSs, JNDAs and MAAs), and has extensive international experience, having submitted applications to the FDA, Canada, Europe, Switzerland, Australia, Israel, Japan, etc.

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