The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index) is a list of new animal drugs intended for use in minor species that have had their safety and effectiveness affirmed through an alternative FDA review process. In many cases, minor species drug products are intended for uses that cannot reasonably go through the standard drug approval process. They are often intended for use in species too rare or varied to be used in traditional safety and effectiveness studies. The Index will be especially helpful to individuals treating animals or classes of animals representing markets too small to support the costs of the drug approval process, even with the incentives of the Minor Uses and Minor Species (MUMS) Animal Health Act of 2004.
As an alternative to the drug approval process for non-food producing minor species and non-food early life stages of food producing minor species, indexing provides a faster and less expensive process to obtain legal marketing status for eligible products.
The Office of Minor Use and Minor Species Animal Drug Development (OMUMS) is following the implementing regulations for indexing to administer this provision of the statute. The regulations lay out how the agency makes determinations regarding the following:
- the eligibility of a new animal drug for addition to the Index,
- the selection of a qualified expert panel to review certain information regarding the new animal drug, and
- whether the agency agrees with the recommendation of a qualified expert panel that a drug be added to the Index.
Also included in the regulations are the content and format requirements for various submissions of information to the agency.
- The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
- The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species - Excel Version
- Final Rule: Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
- 21 CFR 516 Subpart C
- CVM GFI #201 SECG for Index of Legally Marketed Unapproved New Animal Drugs for Minor Species