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
