FDA Approves First “Breakthrough Therapy” Drug

by Long Island Attorney Paul A. Lauto, Esq./www.liattorney.com In our August 5, 2013 blog entitled “Big Pharma Says Jump And The FDA Says How High?”, we detailed how Big Pharma has successfully circumvented cumbersome FDA testing for many drugs with the 2012 passage of the FDA Safety and Innovation Act (FDASIA).  The FDASIA streamlines approval for new drugs … Continue reading FDA Approves First “Breakthrough Therapy” Drug