FDA: INDs and Clinical Protocols Require Registry Certification

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. The certification provision, which took effect Dec. 26, 2007, is part of the clinical trial registry clause of the FDA Amendments Act (FDAAA), which requires submitting clinical trial information (excluding Phase I and small device trials) to the online NIH database, ClinicalTrials.gov.
Clinical Trials Advisor