Ochsner Health is a system that delivers health to the people of Louisiana, Mississippi and the Gulf South with a mission to Serve, Heal, Lead, Educate and Innovate.
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
Over 700 clinical trials
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