美国I期临床信息修订也可以参考一下这两份：
Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived（http://lib.shilinx.com/wiki/index.php?title=FDA_Content_and_Format_of_Investigational_New_Drug_Applications_(INDs)_for_Phase_1_Studies_of_Drugs,_Including_Well-Characterized,_Therapeutic,_Biotechnology-derived_Products）
Guidance for Industry INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information（http://lib.shilinx.com/wiki/index.php?title=Guidance_for_Industry_INDs_for_Phase_2_and_Phase_3_Studies_Chemistry%2C_Manufacturing%2C_and_Controls_Information&searchText=Guidance%20for%20Industry%20INDs%20for%20Phase%202%20and%20Phase%203%20Studies）
美国I期临床试验药品发生生产场地变更，主要参考 Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators
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建议您具体说说变更的哪类信息，是临床方案？还是CMC？还是非临床？
是I期临床试验用药品，发生生产场地变更，目前在美国做一期临床。