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Tag: bioequivalence

FDA Authorization of Generics: Legal Basis and Approval Process

FDA Authorization of Generics: Legal Basis and Approval Process

The FDA approves generic drugs through the ANDA pathway under the Hatch-Waxman Act, ensuring they match brand-name drugs in safety, strength, and bioequivalence. Learn how the legal and scientific process makes generics affordable without compromising quality.

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Bioequivalence for Inhalers, Patches, and Injections: How Generic Drugs Match the Originals

Bioequivalence for Inhalers, Patches, and Injections: How Generic Drugs Match the Originals

Bioequivalence for inhalers, patches, and injections ensures generic drugs work like the originals-not just in blood levels, but in how they're delivered. Learn how regulators test these complex systems and why it matters for patient safety.

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