FDA recommends that your regulatory submissions include a discussion of each of the following key animal study features, in addition to the requirements outlined in 21 CFR 58.185:

• introduction, including a rationale for the selection of the particular animal model
• the study assurances (e.g., USDA registration, AAALAC accreditation, NIH Office of Laboratory Animal Welfare [OLAW] Assurance Statement number)
• the purpose of each test protocol
• the study schedule
• any ex vivo tissue characterization
• any limitations imparted by the choice of the animal model and any amendments and deviations from the original test protocol

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