FDA Cracks Down on ClinicalTrials.gov Reporting Failures
FDA Law Blog
MAY 3, 2021
The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission, such as a New Drug Application or 510(k) premarket notification.
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