Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 15 May 2017 | By Michael Mezher
The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA).
The move, part of FDA's program alignment, is aimed at more closely aligning the agency's inspection efforts with the various products it regulates.
"Specializing by FDA-regulated product type more closely mirrors the organizational model of FDA's centers and the industries we regulate," FDA writes.
Under the agency's previous regional model, ORA was organized across five regional offices and 20 district offices.
Now, the agency is replacing the five regional offices—Central, Pacific, Northeast, Southeast and Southwest—with seven product or operations aligned offices:
Each office, with the exception of the Tobacco Operations Program, is further broken up into two or more regional divisions, which in turn will be served by the agency's 20 existing districts and 13 field laboratories.
According to FDA, the field laboratories will also be aligned by product area, focusing on food, medical products and tobacco, or both.
In March, FDA spokesperson Lyndsay Meyer told Focus the agency will not be closing any offices, and that none of ORA's staff would lose their jobs or be asked to relocate as a result of the restructuring.
Tags: Program Alignment, Office of Regulatory Affairs, Inspections