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U.S. Food and Drug Administration
horizonal rule

When to Contact the Office of the Ombudsman

The Ombudsman reports directly to the Associate Commissioner for External Relations in FDA's Office of the Commissioner. The office works to resolve problems with FDA or to provide information to individuals or companies to enable them to proceed independently if they choose. The office can assist in determining an appropriate path to problem resolution by presenting the available options.

Typical problem areas include:

  • review of marketing or investigational applications.
  • import or export issues.
  • responses to a citizen petition or a general inquiry.
  • responses from an FDA district, center, division, or office.
  • claims of unfair or unequal treatment.
  • other FDA action (or lack of action).
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