Infectious Otitis Externa Drugs for Topical Use in Dogs; Draft Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #281 entitled "Infectious Otitis Externa Drugs for Topical Use in Dogs." This draft guidance provides recommendations to help sponsors complete the effectiveness, target animal safety, and labeling technical sections of a new animal drug application (NADA) for infectious otitis externa drugs for topical use in dogs.
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