About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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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