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# FDA Ombudsman Recommends Stakeholder Education
- URL: https://www.fdaweb.com/fda-ombudsman-recommends-stakeholder-education/
- Published: 2025-05-08T12:00:00.000Z
- Updated: 2026-09-14T15:11:22.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5159141

The FDA Office of Inspections and Investigations (OII) Ombudsman Program recommends that the agency explore developing a Stakeholder Education Hub, perhaps as a dedicated Web page that brings together existing educational resources organized around common concerns in a question-and-answer format. The recommendation is included in the program’s 2024 [annual report](https://www.fda.gov/media/186113/download?ref=fdaweb.com). It says the new hub is needed because external stakeholders frequently report difficulty accessing clear, centralized information about regulatory expectations and navigating critical OII processes such as inspections, import alerts, investigations, and sample collections.

“A dedicated Web site could also serve as a single, accessible entry point for stakeholders seeking clear, process-specific guidance, timelines, and expectations,” the report says.

The ombudsman suggests the hub include:

- a curated list of frequently asked questions addressing commonly reported concerns;
- visual tools such as decision trees, flowcharts, and timelines to simplify complex processes;
- integration with existing resources and links to relevant guidances; and
- a framework that can grow to include feedback-informed Webinars and recorded question-and-answer sessions.

The report says the ombudsman received 334 inquiries in 2024, a 5% increase from 2023\. It says 88% of those inquiries were resolved informally, helping stakeholders avoid unnecessary escalation to formal disputes. “This resolution rate highlights the program’s continued commitment to efficient and timely issue resolution,” it says.

The ombudsman also facilitated 38 stakeholder meetings or facilitated discussions and participated in 13 outreach activities, including presentations, training sessions, and virtual engagement events.

Having so far survived the agency reductions in force, the OII ombudsman program says it will build on 2024’s progress “by continuing to enhance data collection and analysis, expanding outreach to additional stakeholder groups, and supporting broader FDA efforts to bolster regulatory efficiency and responsiveness.”