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Note that the Orange Book includes only drugs approved by the Center for Drug Evaluation and Research at the FDA, not the Center for Biologics Evaluation and Research, and does not include biological... 1.000

👤 The author 📋 Blog 🏷️ FDA , Drugs , Regulation

Simplified: The Orange Book includes only drugs approved by the FDA's CDER not CBER and excludes biological products.

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1 month ago