Abstract
The integration of biotechnology into the traditional regulatory framework of drugs and biologics has produced the need to reexamine traditional definitions and the way in which products of biotechnology are handled by regulatory agencies. The concept that biological products can only be adequately addressed by rigid process control, coupled with reliance on biological assays, has to be readdressed in the light of scientific advances in physicochemical characterization. At the same time, it is necessary to prevent the introduction of new quality control procedures without adequate discussion. Preclinical safety testing of biotechnology products is continually evolving and should not be obstructed by premature guidelines. Finally, the emergence of the biotechnology industry has catalyzed changes in drug regulation worldwide, with major impact on the regulation of synthetic products.
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