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Post-Approval Changes

Meaning

Post-Approval Changes are any modifications made to a drug product, its manufacturing process, labeling, facilities, or quality control procedures after the regulatory agency, such as the FDA, has granted initial marketing approval. These changes are an inevitable part of a product’s lifecycle, driven by process improvements, increased scale of production, or updates to clinical data. They are rigorously classified into major, moderate, or minor categories, each requiring a specific level of regulatory notification.