The act creates faster, more flexible FDA drug and biologic review, new drug and device approval pathways, increases FDA funding, and reduces EHR administrative burdens.
On December 13, 2016, President Obama signed into...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