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What the FDA Orange Book Actually Covers (and What It Has Never Covered) The Orange Book, officially titled Approved Drug Products with Therapeutic Equivalence Evaluations , was established through federal rulemaking in 1980 and became structurally critical after the Drug Price Competition and Patent Term Restoration Act of 1984, universally called the Hatch-Waxman Act

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Following the study period of 12 weeks, the concentration of fasting glucose, glycosylated hemoglobin, and diabetes control was measured

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As previously reported, both PD-1 injection and WCV injection significantly reduced MCA205 tumor progression (TP) (Fig