How does the guidance address potential adverse effects on animal health?
A. The guidance recommends that the developer submit data and information addressing the health of the GE animals, including veterinary and treatment records, growth rates, reproductive function, and behavior. The guidance also recommends submission of data on the physiological status of the GE animals, including clinical chemistry, hematology, histopathology, and post-mortem results. And the guidance recommends submission of data addressing whether the rDNA construct or its expression products cause any direct or indirect toxicity to the animals. Q: Does FDA address animal welfare issues? How do they differ from animal health issues? A: Animal welfare generally refers to how animals are treated, including the conditions under which they are housed. To the extent that such issues affect animal health or the safety of products from the animals, FDA does take such issues into account in its review. However, other unrelated animal welfare issues are not within the scope of the guidance. U
