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

 
• By Bowman Cox

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.

Complaints
no more complaints for ora/oii • Source: Shutterstock

A major reorganization that the Food and Drug Administration proposed 13 December for departmental review includes a new change stripping complaint-handling responsibilities from the agency’s field organization, the Office of Regulatory Affairs.

Sparked by a lost whistleblower complaint, the revamping of the agency’s Human Foods Program and field operation makes both the food program and the agency’s product centers (such as the Center for Drug Evaluation and Research) responsible for receipt, triage and closing of consumer and whistleblower complaints. The centers and field offices have been sharing this responsibility

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