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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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