U.S. Food and Drug Administration. Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated. . Animal Safety. Amey L. Adams, PhD
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Notice: Archived Document
The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.
Amey L. Adams, PhD
Center for Veterinary Medicine
Food and Drug Administration
November 4, 2003
Surrogate Dam and Fetus
Cell Fusion Through
Development of hydrops, normal expulsion of non-viable conceptus, return to cycling, reproductive tract exams
Surrogate Dams and Newborn Clones
Birth weight, evidence of hydrops or dystocia, dam’s readiness for delivery, onset of lactation and mothering behavior, newborn organ function and IgG levels
Growth and development, feed intake, activity level, blood clinical chemistry, heart and lung function, disease incidence
Onset of puberty, estrous cycling and behavior, breeding soundness, sperm motility and morphology, reproductive tract exams, hormone profiles, breeding success, delivery of healthy offspring
Growth to maturity, gait, activity level, blood clinical chemistry, heart and lung function
Frequency of these anomalies were not reported
Some of these animals had more than one anomaly
Cryptorichidism and dwarfism may be related to genetics of nuclear donor
Hyperkeratosis (dermatitis vegetans) rarely a recessive gene
Question 1: Based on what we have presented, has the risk assessment adequately identified the hazards and characterized the risks relating to animal health?