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Zdrowie i gospodarka · 22/11/2006

Draft Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment." Sinusitis is a common disease affecting an estimated 16 percent of the adult U.S. population annually. At present, other than antimicrobials, the treatment options for sinusitis are limited. This guidance is intended to assist the pharmaceutical industry in designing clinical development programs for nonantimicrobial drug products for the treatment of sinusitis.

Source: Federal Register — Food and Drug AdministrationOpen original release →