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Post# of 689157
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Lykiri

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Lykiri

Re: ATLnsider post# 612474

Friday, 07/21/2023 7:09:55 PM

Friday, July 21, 2023 7:09:55 PM

Post# of 689157
ATLnsider,

IMO, BLAs are submitted in a format known as the Electronic Common Technical Document (eCTD). The eCTD is organized into five modules. Module 1 is country or region specific and contains the information that is unique to a region. Module 2 contains summary documents for Modules 3–5.(Quality- Safety- Efficacy)
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