Month: October 2011

By Jennifer D. Newberger – On September 30, 2011, FDA announced the issuance of a Draft Guidance, De Novo Classification Process (Evaluation of Automatic Class III Designation), intended to update and streamline the de novo review process. The de novo review process, formally known as Evaluation of …

By Ricardo Carvajal – FDA released an ambitious Draft Strategic Plan for 2012-2016 to guide the activities of its Foods and Veterinary Medicine ("FVM") Program (meaning the activities of CFSAN and CVM, as well as ORA’s food-related activities).  The Plan articulates priorities organized around the following …