A sponsor can apply for Designation status for Minor Use and Minor Species drugs prior to their approval or conditional approval. It makes the sponsor eligible for incentives to support the approval or conditional approval of the designated use.
via What's New: Animal & Veterinary http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm125445.htm
via What's New: Animal & Veterinary http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm125445.htm
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