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In the United States, biotechnology are subject to licensure under the Public Health Service Act. A biologic product is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment or cure of diseases or injuries to humans. Biological products include, but are not limited to, bacterial and viral vaccines, human blood and plasma and their derivatives, and certain products produced by biotechnology, such as interferons and erythropoietins.
The FDA regulates biotechnology through it's Center for biotechnology Evaluation and Research (CBER). FDA's Center for biotechnology Evaluation and Research CBER is responsible for ensuring:
the safety of this nation's entire blood supply and the products derived from it;
the production and approval of safe and effective childhood vaccines, including any future AIDS vaccines;
the proper oversight of human tissue for transplantation;
an adequate and safe supply of allergenic materials and anti-toxins;
the safety and efficacy of biological therapeutics, including an exciting new array of biotechnology-derived products used to treat diseases such as cancer and AIDS.
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The PHS Act requires individuals or companies who manufacture biotechnology for introduction into interstate commerce to hold a license for the products. These licenses are issued by FDA's Center for biotechnology Evaluation and Research (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.
Manufacturers of those products are now required to submit only a biotechnology license application (BLA),
For more information, please contact Global Regulatory Inc. at 403-770-1994 or email Global Regulatory
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