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FDA Guidance on Sinusitis and Its Potential Impact on Treatment

by Bradley F. Marple, MD •

The FDA responded, in turn, with the announcement of a proposed draft guidance in November 2006, titled Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment. In this document, chronic sinusitis is defined as an inflammation of the sinuses …when duration is longer than 8 weeks.9 As with many of the opposing points of view that were earlier argued, the main points of difference were those of nomenclature and duration of therapy. Rebuttals were submitted by several sources, the draft guidance, however, was posted with no changes made in the definition.10

Although the definition offered by the FDA for chronic sinusitis differs somewhat from that originally developed by the Task Force on Chronic Rhinosinusitis, the issue that is most relevant to the standardized drug development is the endorsement of a definition by the FDA that is based on the inflammatory response that is common to the disease. This constitutes the next step in establishing the collaborations necessary for medical treatment development, and will hopefully usher in a new era of concept development, testing, and implementation of therapies for CRS that are held to the same efficacy and safety standards common to FDA-approved interventions.

References

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  9. www.fda.gov/cder/guidance/7316dft.pdf.
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  10. www.fda.gov/ohrms/dockets/dockets/06d0463/06d-0463-c000001-01-vol1.pdf.
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