Final guidance, final rule; potato, potah-to, yes? No. According to Daniel Gottlieb of Epstein Becker Green, despite popular misconception in both mass media and among senators, U.S. Food and Drug Administration “guidances and final rules carry different legal weight.”
A guidance is just that. It’s meant to help interpret or clarify an existing regulation, explains Gottlieb. Whereas a regulation is a legislative rule with the “force of the law,” he says. The FDA delineates this difference directly, stating clearly on its website, “FDA regulations are also federal laws,” but “FDA guidance describes the agency’s current thinking on a regulatory issue.”
