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Regulatory agencies such as the FDA and EMA classify live modified microorganisms as higher-risk biological products, necessitating extensive preclinical safety evaluation, including assessment of genetic stability, exclusion of horizontal gene transfer, immunogenicity testing, and environmental biosafety analyses (Rouanet et al., 2020
2.3 The Defendant's Response The defendant must respond to the complaint within a specified time
When approving Wegovy, the FDA referenced a clinical trial where those who received Wegovy lost an average of 12.4% of their body weight, with an average BMI of 38 in the participants
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