The FDA regions will now be divided into five districts each with a lead office for field activities as well as providing guidance on imports, inspections, and enforcement policy. According to the notice district will be organized by FDA-regulated product, which will, “enhance the effectiveness of our communications, our processes, and our ability to keep pace with scientific innovation and protect public health.”
The ORA Program Alignment will go into effect on May 15, 2017.
The notice can be accessed at:
fda.gov