1. 使用define.xml,而不是define.pdf递交metadata
2. 21 CFR Part 11
电子记录取代手写记录
3. electronic Common Technical Document (eCTD)
4. Case Report Tabulations (CRTs)
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标签:FDA,Document,记录,递交,规定,define,Tabulations From: https://www.cnblogs.com/SAS-T/p/16860779.html