The U.S. Food and Drug Administration (FDA) has submitted two regulatory proposals that would expand the rules concerning who has access to investigative treatments. The new proposals would provide a clearer pathway for certain critically ill patients so they can be considered for access to investigative drugs without enrolling in a clinical trial.Both proposals have been submitted to the Office of Management and Budget (OMB), where they will be reviewed for approval.

If the FDA’s two proposals clear the OMB review process, they would be released for public comment before taking effect.