FDAAA requires the reporting of summary results information no later than 1 year after the completion date for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of FDCA. However, NIH encourages results reporting for all NIH-supported clinical trials registered in ClinicalTrials.gov, regardless of whether or not they are required under FDAAA.
