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Data Integrity Is a Leadership Problem, Not a Regional One: Lessons from 2025 FDA Warning Letters Executive Summary This report provides an evaluation of US FDA Warning Letters issued in calendar year 2025 that cite 21 CFR 211.68(b), focusing on automated and computerized systems used to generate, p

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In February 2026, the FDA publicly announced its intent to take action targeting mass-marketed, non-FDA-approved compounded GLP1 products, emphasizing that promotional claims implying equivalence to FDAapproved drugs can trigger enforcement risk