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Thanks Glen. This is helpful. Regards, Goutham ------------------------------ GOUTHAM REDDY KANCHARLA Gaithersburg MD United States ------------------------------

Hi, Can you please comment if there is any FDA guidance document available on the transmission of annotated ecg data through ESG? Much appreciated if you can share your experience of dispatching ECG data through ESG. Thank you. ------------------------------ GOUTHAM REDDY KANCHARLA Gaithersburg ...

Thanks Glen. ------------------------------------------- Original Message: Sent: 28-May-2020 12:00 From: Glen Park Subject: Submission Date in FDA Forms and Cover Letter The dates on the documents are not part of the eCTD validation criteria. I have never had a submission rejected because ...

Hi Glen, Thanks for your response. There will be situations where submission is planned on a specific day but gets pushed by a day or two due to some constraints. In these situations, sponsors usually change the submission date in Form 1571 and cover letter and resign the documents. My intention is ...