PDA Letter Article

FDA's ORA Realignment, MRA, NIPP, Concept of Operations: How it All Fits Together

by Rebecca Stauffer, PDA

November December 2018

Just over a year ago, the U.S. FDA released detailed information about the restructuring of the newly realigned Office of Regulatory Affairs (ORA) (1). Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, provided an update on this and other ORA initiatives on Sept. 24 in the second plenary of the 2018 PDA/FDA Joint Regulatory Conference.