FDA HHS

The Food and Drug Administration (FDA)
is an HHS agency that regulates clinical
investigations of products under its jurisdiction,
such as drugs, biological products, and medical
devices. FDA regulations are published as part
of chapter 21 of the CFR, and FDA’s human
subject protection regulations are in parts 50,
56, 312 and 812.
For more information, please visit FDA’s
website page on Running Clinical Trials and the
sub-page on Regulations.