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.

To best characterize the device effects on the animal, FDA recommends that the process be active and specific, rather than passive and general. Important attributes to consider for evaluation include, but are not limited to:

  • respiratory rate, pattern, and depth
  • blood pressure
  • heart sounds and pulse character
  • mucus membrane color at rest and under exertion
  • attitude
  • mentation
  • gait
  • presence or absence of abdominal, bladder, or bowel distension

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