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U.S. Food and Drug Administration
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Office of the Ombudsman

The Food and Drug Administration (FDA) is committed to the principle that regulated industry has a right to disagree with an agency decision, action, or operation, and that full and open discussion of issues in controversy produces a better decision in the end. Moreover, regulated industry is entitled to receive high quality administrative practices and procedures from all parts of FDA. The goal of FDA's Ombudsman is to help ensure that the agency fulfills its regulatory responsibilities well. In the short term, the Office is dedicated to facilitating problem resolution. In the long term, the Office looks at issues systematically in order to make the process work better. Thus it welcomes more general complaints, comments, and suggestions about FDA's regulatory processes.

Inevitably, a variety of problems arise. When a member of the regulated industry has a concern about an agency action, getting the problem resolved can be confusing, frustrating, and time-consuming. The services of the Office of the Ombudsman, which has agency-wide jurisdiction, are available to any company or individual with a dispute with FDA. The Office works in a range of ways, from a confidential consultation, in which options are discussed and practical guidance is offered, to taking an active role in resolving the problem or investigating the situation.

The Office of the Ombudsman's main function is to explore complaints and assist in resolving disputes between companies or individuals and agency offices.

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