Tag: FDA
The Orange Book: Understanding Therapeutic Equivalence and Generic Drug Substitution
Jan 26 2026 / Healthcare ResourcesThe FDA's Orange Book is the official guide to therapeutic equivalence between brand-name and generic drugs. Learn how TE codes determine substitution, why it matters for patients and pharmacies, and how the system saves billions annually.
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Complex Generic Formulations: Why Proving Bioequivalence Is So Hard
Jan 10 2026 / MedicationsProving bioequivalence for complex generics like inhalers, creams, and patches is far harder than for regular pills. Without blood-level tests, manufacturers face reverse-engineering challenges, unstable formulations, and conflicting global standards - delaying affordable alternatives.
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