Attorney: Uncertainty Looms On Cures 'Common Rule' Implementation

An industry attorney said there is continued uncertainty over how HHS and FDA will implement 21 st Century Cures language that calls for harmonization of the two regulators' human research subject protection regulations even though HHS just issued a final rule revising its regulation of the so-called Common Rule. The attorney argues harmonization is still needed because of the significant burden researchers faced in trying to resolve the regulatory differences, but a key consumer advocate told Inside Health Policy that...