FDA Requirements for Brand-Name and Generic Drugs are 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.

 

MC9004413101

 

MC9004413101

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

 

MC9004413101

 

MC9004413101

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

 

MC9004413101

 

MC9004413101

FDA reviews the actual drug product.

 

MC9004413101

 

MC9004413101

FDA reviews the drug's labeling.

 

MC9004413101

 

MC9004413101

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

 

MC9004413101

 

MC9004413101

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

 

MC9004413101

 

MC9004413101

FDA periodically inspects manufacturing plants.

 

MC9004413101

 

MC9004413101

FDA monitors drug quality after approval

 

MC9004413101

 

MC9004413101

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