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What are the elements of an animal study?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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