Electronic Common Technical Document (eCTD) and Study Data (7of15) RedI - May 29-30, 2019
ฝัง
- เผยแพร่เมื่อ 2 มิ.ย. 2024
- CDER Office of Business Informatics’ Jonathan Resnick and Chao (Ethan) Chen discuss eCTD background, guidance, and metrics; points to consider when preparing to submit electronically; and electronic submission processing. Chen covers technical rejection criteria for study data.
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