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Thursday, September 14, 2017

FDA Issues Draft Guidance on the Indexing of Legally Marketed Unapproved New Animal Drugs for Minor Species

The U.S. Food and Drug Administration has issued draft guidance for industry, “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.”

Drugs listed on the Index are unapproved but can be legally marketed for specified use(s) in specified minor species. Indexing is allowed for drugs that are intended for use for:
  • Non-food-producing minor species, such as pet birds, hamsters, zoo animals, and ornamental fish. These animals are typically not eaten by people or food-producing animals; and
  • An early non-food life stage of a food-producing minor species, such as oyster spat (immature oysters). Because people do not generally eat oyster spat, a drug to treat a disease in spat can be indexed, but a drug to treat a disease in adult oysters, which people commonly eat, cannot be indexed.
Read entire press release.

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