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How are biological products approved?
The PHS Act requires individuals or companies who manufacture biologics for introduction into interstate commerce to hold a license for the products. These licenses are issued by CBER. Biological products intended for veterinary use are regulated under a separate law, the Virus, Serum, and Toxin Act, which is administered by the U.S. Department of Agriculture. Licensing of biologic products under the PHS Act is very similar to the new drug approval process for human drugs. Following initial laboratory and animal testing, a biological product is studied in clinical trials in humans under an investigational new drug application (IND). If the data generated by the studies demonstrate that the product is safe and effective for its intended use, the data are submitted to CBER as part of a biologics license application for review and approval for marketing. After a license application is approved for a biological product, the product may also be subject to official lot release. As part of the manufacturing process, the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to official release by CBER, the manufacturer submits samples of each lot of product to CBER together with a release protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer's tests performed on the lot. CBER may also perform certain confirmatory tests on lots of some products, such as viral vaccines, before releasing the lots for distribution by the manufacturer. In addition, CBER conducts laboratory research related to the regulatory standards on the safety, purity, potency, and effectiveness of biological products.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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