title: An overview of safety and regulatory aspects of the new biotechnology.
abstract: New technology is producing new drugs and biologic products that present novel safety issues for the regulatory agencies. These products are produced using recombinant DNA or hybridoma techniques. Examples are growth hormone, antihemophilic factor, and interferon, produced by recombinant DNA. Very special proteins, namely, monoclonal antibodies, can be made by hybridoma technology that are extremely pure and potent. At present over two dozen in vitro monoclonal antibody products are approved by FDA and many more are expected. Regulating these products posed some new questions for the FDA, regarding the kinds of safety tests that should be done to establish reasonable levels of safety before clinical trials or marketing of these agents. The production methods are novel and thus require careful consideration to ensure that risks inherent in those methods do not cause disease when these products are administered to human subjects. A general overview of the regulatory safety issues of these new products is given.
mesh_terms: D000911:Antibodies, Monoclonal; D004274:DNA, Recombinant; D006801:Humans; D007372:Interferons / Q000096:biosynthesis / Q000633:toxicity; D007878:Legislation as Topic; D014481:United States
chemical_list: D000911:Antibodies, Monoclonal; D004274:DNA, Recombinant; D007372:Interferons