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Same FDA Requirements for Brand-Name and Generic Drugs |
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Brand-Name Drug |
Generic |
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For reformulations of a brand-name drug or generic versions of a drug, FDA reviews data showing the drug is bioequivalent to the one used in the original safety and efficacy testing.
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FDA evaluates the manufacturer's adherence to good manufacturing practices before the drug is marketed.
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FDA reviews the active and inactive ingredients used in the formulation before the drug is marketed.
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FDA reviews the actual drug product. |
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FDA reviews the drug's labeling. |
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Manufacturer must seek FDA approval before making major manufacturing changes or reformulating the drug.
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Manufacturer must report adverse reactions and serious adverse health effects to the FDA. |
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FDA periodically inspects manufacturing plants.
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FDA monitors drug quality after approval |
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