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Manufacturing Changes and Generic Approval: What Triggers FDA Re-Evaluation
Daniel Whittaker

Manufacturing Changes and Generic Approval: What Triggers FDA Re-Evaluation

Understanding what manufacturing changes trigger FDA re-evaluation for generic drugs is critical for manufacturers and patients alike. From facility moves to formulation tweaks, not all changes are equal - and the rules determine whether a drug stays on the shelf or gets pulled for review.

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RxStore-365: Your Comprehensive Pharmaceuticals Guide

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