"Without adequate testing and confirmation of reliability of supplier test results, you lack scientific evidence that the components or drug products conform to appropriate specifications prior to use in the drug products you manufacture," the agency added
Higher-risk situations may include: Older age Existing sarcopenia or frailty Recent falls Difficulty rising from a chair Low baseline physical activity Very low protein or calorie intake Rapid or excessive appetite suppression Chronic kidney, liver, pulmonary, or cardiovascular disease Cancer or another catabolic illness Recent hospitalization Significant gastrointestinal adverse effects Very rapid weight loss Inability to participate in resistance exercise These factors do not automatically make GLP-1 therapy inappropriate
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Following the resolution of those issues, Judge Marston is expected to direct the parties to select representative GLP-1 lawsuits for early bellwether test trials, to help gauge how juries will respond to evidence and expert testimony likely to be repeated throughout the litigation