IND Submissions With New Protocols Must Certify Trial Registration

摘要

Drugmakers submitting INDs with new clinical trial protocols are advised to certify to the FDA that they have met all requirements of the clinical trial database registry law, according to a final guidance.rnThe certification provision, which took effect Dec. 26, 2007, stems from the clinical trial registry clause of the FDA Amendments Act (FDAAA) and requires submission of clinical trial information (excluding Phase I and small device trials) to the online NIH database, ClinicalTrials.gov (WDL, Oct. 1, 2007). The guidance says National Clinical Trial (NCT) control numbers should be included with submissions, where applicable.