Lexology November 8, 2022
Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject protection regulations and the Federal Policy for the Protection of Human Subjects, known as the “Common Rule.” The proposals aim to harmonize FDA’s human subject projection rules with the Common Rule, except where not allowable due to differences in statutory authority, and would promulgate a single IRB requirement under FDA’s regulatory authority.
HHS seeks comments on the proposed rules through November 28.
Background
FDA’s rules on human subject protection govern clinical investigations under sections 505(i) and 520(j) of the Federal Food, Drug, and Cosmetic Act (FDCA), as well as studies used to support applications for research or marketing permits...
Today's Sponsors
Today's Sponsor