Frequently Asked Questions

What are the elements of an animal study?

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Compliance & Regulatory: Biopharma
Compliance & Regulatory: MedTech
Guidelines & Standards

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