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Same FDA Requirements
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Brand-Name Drug |
Generic Drug |
For reformulations of a brand-name drug or generic versions of a drug, the 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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