FDA Enforcement in 2025: What the Data Reveals So Far
2025 is shaping up to be another highly active year for the FDA enforcement of Current Good Manufacturing Practices (cGMPs). As I have been reviewing 2025 warning letters, one thing
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2025 is shaping up to be another highly active year for the FDA enforcement of Current Good Manufacturing Practices (cGMPs). As I have been reviewing 2025 warning letters, one thing
In September 2025, the U.S. Food and Drug Administration (FDA) issued a new guideline titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications”. Purpose and Scope This article outlines
A Summary of Quality-Driven Growth as the New Strategy for Life Sciences Leaders In the highly regulated world of life sciences, encompassing biopharmaceuticals, medical technology (MedTech), and Pharmaceuticals, quality has
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