Learn how the FDA approves generic drugs under the Hatch-Waxman Act, including the ANDA process, bioequivalence requirements, patent challenges, and how this system keeps prescription costs low for millions of Americans.
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Authorized generics let brand drug companies stay competitive after patent expiration by selling the exact same medication under a different label. They lower prices, reduce patient confusion, and challenge traditional generics-but they also spark debate over market fairness.
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