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The National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) announces a public meeting and requests input from interested parties on regulations to be developed to expand the clinical trial registry and results data bank commonly known as ClinicalTrials.gov in accordance with provisions contained in section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires the Secretary of HHS to hold a public meeting to provide an opportunity for input from interested parties with regard to regulations to be issued within three years of enactment of the law. NIH is seeking input from all parties with an interest in clinical trials information on a range of issues to be considered in the rulemaking, including the possible inclusion of results information for clinical trials of drugs, biological products and devices that are not approved by the FDA, the submission of narrative summaries of the results of applicable clinical trials, adverse event reporting, and modifications to the registration information that is required to be submitted to the data bank.
Public meeting on clinical trials [electronic resource] / National Institutes of Health and the National Library of Medicine.
Author:
National Institutes of Health (U.S.)
Publisher:
[Bethesda, Md. : National Institutes of Health, 2009]
Abstract:
(CIT): The National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) announces a public meeting and requests input from interested parties on regulations to be developed to expand the clinical trial registry and results data bank commonly known as ClinicalTrials.gov in accordance with provisions contained in section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires the Secretary of HHS to hold a public meeting to provide an opportunity for input from interested parties with regard to regulations to be issued within three years of enactment of the law. NIH is seeking input from all parties with an interest in clinical trials information on a range of issues to be considered in the rulemaking, including the possible inclusion of results information for clinical trials of drugs, biological products and devices that are not approved by the FDA, the submission of narrative summaries of the results of applicable clinical trials, adverse event reporting, and modifications to the registration information that is required to be submitted to the data bank.
Subjects:
Clinical Trials Data Monitoring Committees Clinical Trials as Topic United States
