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U.S. Food and Drug Administration
horizonal rule

Dispute Resolution

The Office of the Ombudsman is a resource for individuals and for companies when they are experiencing problems with the regulatory process or with the application of FDA policies or procedures. The Office of the Ombudsman provides assistance if there are problems or concerns that are not being addressed, or cannot be addressed, at the center or district level, or when there are concerns about raising an issue at that level. If requested, confidentiality will be maintained by the Office of the Ombudsman to the greatest extent possible.

The Office of the Ombudsman works to resolve issues and problems and to find approaches that are acceptable to both the affected company and the FDA. The Office works to ensure that issues have been fairly heard by considering the basis for an FDA action or position; considering issues of consistency within and among Centers; and, where appropriate, providing information or explanations to the complainant regarding the result. Matters brought to the Office range widely in scope and complexity. Most involve complaints about the FDA's processing of various submissions and review of import and export issues. The Office refers certain matters, including allegations of wrongdoing or potential criminal matters, to other FDA offices. This office does not get involved in matters currently in litigation.

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