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What is Public Law 110-85, (also known as the FDA Amendments Act) and how does it relate to ClinicalTrials.gov and NIH-funded clinical trials?

April 26, 2017ACT amendments clinical trials clinicaltrials.gov fda known Law public relate

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What is Public Law 110-85, (also known as the FDA Amendments Act) and how does it relate to ClinicalTrials.gov and NIH-funded clinical trials?

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On September 27, 2007, the President signed Public Law 110-85 http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf (PDF – 424 KB). The law includes a section on clinical trial databases (Title VIII) that expands the types of clinical trials that must be registered in ClinicalTrials.gov, increases the number of data elements that must be submitted, and also requires submission of certain results data.