WebIn 2007, the US Congress enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA) 1.According to its Section 801, also known as FDAAA 801, responsible parties are required to post basic results of completed clinical trials to Clinicaltrials.gov. Submitting the results became available from September 2008, when the … WebFDAAA 801) Update/verify “active” trials once every 6 mo. (ClinicalTrials.gov) Consider any protocol amendments that impact registration. Recruitment status and (primary) completion date must be updated within 30 days of a change (FDAAA 801) Certification of Compliance to NIH. Applies to: All grants supporting ACTs (even if only supporting ...
ClinicalTrials.gov Final Rule (42 CFR Part 11) Information
WebSection 801 of the Food and Drug Amendments Act, known as FDAAA 801, requires registration and results reporting on the government web site called ClinicalTrials.gov for studies that meet the definition of “Applicable Clinical Trial”. Click here to evaluate whether your study is an Applicable Clinical Trial (ACT) under 42 CFR 11.22(b).. Under the … Web§ 11.2 What is the purpose of this part? This part implements section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) by providing requirements and procedures for the … sct contact us
ClinicalTrials.Gov Compass
WebSep 19, 2016 · The final rule and an accompanying complementary policy issued by the National Institutes of Health (NIH) represents the formal codification and clarification of requirements first described in Section 801 of the 2007 Food and Drug Administration Amendments Act (FDAAA). WebThe ClinicalTrials.gov registration requirements were expanded after Congress passed the FDA Amendments Act of 2007 (FDAAA). Section 801 of FDAAA (FDAAA 801) requires more types of trials to be registered and additional trial registration information to be submitted. The law also requires the submission of results for certain trials. WebFood and Drug Administration Amendments Act (FDAAA) of 2007. On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration … sctc orientation