美国FDA数据标准项目研究及对我国的启示(6)
[13] Food and Drug Administration. CDER data standards communications plan v1.5[EB/OL].(2018-07-18)[2020-04-25]. https://www.fda.gov/media/115175/download.[14] Food and Drug Administration. Data standards program action plan v1.1[EB/OL].(2013-04-29)[2020-08-29].https://www.federalregister.gov/documents/2013/07/15/2013-16861/electronic-study-data-submission-data-standard-support-availability-of-the-center-for-drug. ......
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