Clinical Trial Disclosure: Global Overview and Implications of New Laws and Guidelines

被引：0

作者：

Kathy B. Thomas

Merete Joergensen

Gerard Lynch

Michael Rubison

Brandon D. Porter

Jacqueline Sayers

Claudia Tesch

机构：

[1] Medical and Scientific Writing and Publication Services,Global Clinical Registry

[2] Novo Nordisk A/S,Global Process Owner

[3] Trial Transparency,Global Regulatory Affairs

[4] Flint Hills Consulting,Product Development Quality, Roche Products Ltd.

[5] LLC,undefined

[6] Johnson & Johnson Pharmaceutical Research & Development,undefined

[7] LLC,undefined

[8] Welwyn Garden City,undefined

[9] Nycomed Deutschland GmbH,undefined

来源：

Drug information journal : DIJ / Drug Information Association | 2010年 / 44卷

关键词：

Clinicaltrials.gov; EMEA; EudraPharm; EudraCT; FDA Amendments Act of 2007 WHO;

D O I：

暂无

中图分类号：

学科分类号：

摘要：

Clinical trial disclosure has received much international attention. The US Congress has enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA), also known as Public Law 110-85. Section 801 of FDAAA requires public registration of new or ongoing clinical trials and disclosure of results for completed clinical trials on the public database ClinicalTrials.gov. FDAAA has provisions for proof of compliance and authorizes penalties for noncompliance; several phases will be implemented over 3 years and completed by 2010.

引用

页码：213 / 225

页数：12

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