Evaluation of compliance with legal requirements under the FDA Amendments Act 2007 for timely registration of clinical trials, data verification, delayed reporting, and trial document submission
The US Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA 2007), as further clarified by regulations effective in 2017 (the Final Rule), requires sponsors of clinical trials covered by the legal requirements to register and report clinical trials to ClinicalTrials.gov.1 In a previous r...
| Main Authors: | , |
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| Format: | Journal article |
| Language: | English |
| Published: |
American Medical Association
2021
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