Scharf Interviewed on Meaning of Proposed FDA Rules for CBE Supplements

Stephanie Scharf was interviewed by the FDA News Washington Drug Letter for her comments on FDA’s proposed revisions to rules regarding “changes being effected” supplements to the labeling of prescription products, which were issued on January 15. Scharf emphasized that the context in which FDA issued its proposed revisions highlight the increasing power of preemption as a defense to state tort failure to warn claims. The entire article may be seen by clicking here.