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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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