More than four years in, officials are still working on draft regulations to further define the ClinicalTrials.gov
submission requirements laid out in the FDA
ClinicalTrials.gov: NIH Busy Educating Sponsors On Mandates While Regs Remain In The Works
Draft rules are still being developed to fully implement ClinicalTrials.gov, but the law has been in effect for some time and officials say they are making a consistent effort to ensure study sponsors are educated on their new responsibilities.