FDA's Role: ClinicalTrials.gov Information | FDA - U.S.
https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/fdas-role-clinicaltrialsgov-information
What Is FDA’s Role Related to ClinicalTrials.gov?What Does FDA Require Regarding Certification?What Are The Informed Consent Requirements Related to ClinicalTrials.gov?Historical Background InformationRelated Information The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that the “Responsible Party” for certain clinical trials register with, and submit the results information of some trials to, the ClinicalTrials.gov databank (www.ClinicalTrials.gov). FDA has been given the following implementation and compliance/enforcement responsibilities r...
The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that the “Responsible Party” for certain clinical trials register with, and submit the results information of some trials to, the ClinicalTrials.gov databank (www.ClinicalTrials.gov). FDA has been given the following implementation and compliance/enforcement responsibilities r...
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