HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


US FDA's s Centers In Charge Of Complaint Handling In Major ORA Reorganization Plan

Executive Summary

Agency proposal, now under HHS review,  further reduces chances of losing another whistleblower complaint by taking ORA out of the loop, while proposing a new name for its slimmed-down field organization: Office of Inspections and Investigations. Meanwhile, an agency veteran, Michael Rogers, will lead the revamped organization as associate commissioner.

You may also be interested in...

‘Largest Reorganization In FDA’s History’: ORA Overhaul Better Thought Of As Agency-Wide Reorg

US FDA's response time and decision consistency on compliance issues should improve under reorganization that aims to take agency processes into the modern era. FDA is already moving forward on steps needed to implement the reorg as it awaits HHS and White House approval.

US FDA’s Office Of Regulatory Affairs To Focus On Investigations, Inspections And Imports

ORA to shed more responsibilities as the FDA focuses the likely-to-be renamed field organization more on inspections while revamping the agency's Human Food Program.

US FDA’s Infant Formula Regulatory Authority Doesn’t Reach ‘All That Needs To Be Fixed’

“This system is fundamentally prone to supply chain disruptions with so few manufacturers,” says Mark Moorman, FDA Office of Food Safety director. In FDLI presentation, he acknowledges delicate balance in stemming distribution of potentially contaminated power formula while sustaining supply.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts