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By referring to the laws and regulations of the United States, FDA guidance documents and implementation guidelines, related news, domestic and foreign literature, we analyzed more deeply the background, content system, social disputes caused by the Right to Try Act and its important breakthroughs of the existing expanded access in this paper, so as to provide reference for the system innovation in China. Although the Right to Try Act emphasizes deregulation, simplification of procedures and relative risk control, it also emphasizes the widening of critically ill patients' right of free choice. Therefore, it is required that the introduction and construction of relevant system norms be comprehensively measured and prudently promoted in Chinese context.

, authors=Zhang-zhi GE, authorsList=Zhang-zhi GE, authorCompany=null, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322627326458839579, articleId=1322627326051992089, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=美国尝试权法案对临床试验用药物扩大使用制度的新发展, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

通过查阅美国的法律法规、FDA指南文件和实施准则、新闻报道和国内外文献，本文深入分析尝试权法案的产生背景、内容体系、引发的社会争议及其对已有扩大使用制度的重要突破，为我国相关制度规范的设计和创新提供借鉴。尝试权法案虽然强调放松监管、简化程序和相对风险控制，但更为重要的是拓宽了危重患者的选择权。立足中国国情，我们需全面衡量并审慎推进相关制度规范的引入和建设。

, authors=葛章志, authorsList=葛章志, authorCompany=null, correspAuthors=null, authorNote=, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=xEfQ5UXYB9O7GYPx/Jzexg==, magXml=hFbMpfQ7gcc/N2V8yg+cCQ==, pdfUrl=null, pdf=P65VvJD/jkC/uf4hXvx4pQ==, pdfFileSize=1556351, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=694FoYYNthjPXSu2/KhA5w==, mapNumber=null, fund=null)}, authors=[Author(id=1322627326777606688, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627326051992089, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=gezhangzhi2008@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322627326836326946, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627326051992089, authorId=1322627326777606688, language=EN, stringName=Zhang-zhi GE, firstName=Zhang-zhi, middleName=null, lastName=GE, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=University of Science and Technology of China, Hefei 230026, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322627326911824419, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627326051992089, authorId=1322627326777606688, language=CN, stringName=葛章志, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=中国科学技术大学，合肥　230026, bio={"content":"

葛章志，男，副研究员，主要从事公共健康政策研究。联系电话：（0551）63607551，E-mail：gezhangzhi2008@163.com。

"}, bioImg=null, bioContent=

葛章志，男，副研究员，主要从事公共健康政策研究。联系电话：（0551）63607551，E-mail：gezhangzhi2008@163.com。

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