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U.S. Department of Health and Human Services

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What is the approval process for a biological product?

In general, biological products that are used to treat or prevent diseases, like traditional drug products, have to be thoroughly tested and shown to be safe and effective in order to enter interstate commerce in the United States.

Following initial laboratory testing, a biological product is tested in humans. FDA oversees the human testing. If the manufacturer believes that the results of the tests show that the product is safe and effective, the manufacturer submits the information to FDA for review and a decision to approve or not.

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