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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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