New guidance intends to limit product sponsors’ exclusions from the requirement to study pharmaceuticals in pediatric patients.
On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft...more
The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion.
On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more
Draft guidance provides the medical industry with long-awaited boundaries for marketing in the electronic age.
On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing...more