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GLP-1 therapies are at risk of entering that same cycle

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Additional violations included: No documented monitoring plan or monitoring reports Enrollment of ineligible subjects (e.g., with low platelet counts) Inadequate documentation of informed consent Unreported adverse device effects (UADEs) Inaccurate device accountability records Why It Matters: Sponsors are legally and ethically accountable for the oversight of their clinical trials

What bacteriostatic water actually is Bacteriostatic water for injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) benzyl alcohol as a bacteriostatic preservative