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FDA Requirements

The FDA requirements for brand-name and generic drugs are the same.

 

Brand Name Drug

Generic Drug

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.

x

x

FDA evaluates the manufacturer's adherence to good manufacturing practices before the drug is marketed.

x

x

FDA reviews the active and inactive ingredients used in the formulation before the drug is marketed.

x

x

FDA reviews the actual drug product.

x

x

FDA reviews the drug's labeling. 

x

x

Manufacturer must seek FDA approval before making major manufacturing changes or reformulating the drug.

x

x

Manufacturer must report adverse reactions and serious adverse health effects to the FDA.

x

x

FDA periodically inspects manufacturing plants.

x

x

FDA monitors drug quality after approval.

x

x

Source: FDA

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