Posted by Michael Wonder on 14 Oct 2019
FDA is smashing the status quo for regulatory science
14 October 2019 - A recent press release from the FDA titled “Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality,” may have sounded like another bland and boring exercise in regulatory rhetoric.
But it actually signals a revolutionary shift in regulatory velocity.
Changes in the FDA’s Office of New Drugs will create enhanced review zones that cross disease areas and divisions to maximize access to more focused and innovative areas of regulatory expertise.
