The ANDA process is the legal pathway the FDA uses to approve generic drugs in the U.S., ensuring they're as safe and effective as brand-name versions without requiring costly clinical trials. Learn how bioequivalence, manufacturing standards, and patent rules shape generic drug access.
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The Orange Book database from the FDA lists approved prescription drugs, their patents, and therapeutic equivalence ratings - enabling generic competition and saving billions in healthcare costs.
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Patent litigation is delaying generic drug launches by years, costing patients billions. Despite FDA approval, legal battles and shady deals keep affordable medicines off shelves. Here’s how the system works-and why it’s broken.
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