Article ID Journal Published Year Pages File Type
10852994 Biologicals 2005 4 Pages PDF
Abstract
The regulatory requirements for licensure of marker vaccines and diagnostic test kits are not different from that for other products. There are several mechanisms for vaccine approval, some more rapid than others, but only a few that could apply to these products. Generally, the platforms that might support marker vaccines and companion diagnostic kits are those based on genetic engineering or protein manipulation. If the product is derived from the application of biotechnology, then additional regulatory considerations are applicable. Most important of these are the considerations found in the National Environmental Policy Act (NEPA), wherein deliberate release of any organism containing recombinant DNA into the environment is subject to review and approval by appropriate federal agencies. Environmental release and NEPA compliance are discussed.
Related Topics
Life Sciences Biochemistry, Genetics and Molecular Biology Biochemistry, Genetics and Molecular Biology (General)
Authors
, ,