JD Supra

FDA (Finally!) Issues Proposed Rule to Amend FDA Regulations on the Protection of Human Subjects and Institutional Review Boards

The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional ...
JD Supra

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the ...
RAPS

Differences Between HHS and FDA Clinical Trial Rules Spark New Guidance

With an eye to reducing confusion between the revised Common Rule from the Department of Health and Human Services (HHS) and the US Food and Drug Administration’s (FDA) regulations, FDA on Friday ...
RAPS

FDA seek to harmonize human subject protections with revised Common Rule

The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human subject protections and Institutional Review ...