ABSTRACT
The revolution in biotechnology is mainly the result of the introduction of genetically engineered microorganisms into a variety of industrial processes, resulting in recombinant DNA drug products. The federal government has recognized that the Food and Drug Administration (FDA) will have to interact with industry and academia in order to deal effectively with regulatory issues regarding recombinant DNA drugs. As the biotechnology revolution gains momentum and these new discoveries follow the arduous path towards becoming approved drugs, the FDA will play the primary and official role in establishing the regulatory requirements for these new drugs. Immunologic potential, pharmacokinetics, and bioactivity of the recombinant DNA drug product are undoubtedly related to the amino acid sequence and/or the structure of the molecule. The scientific accomplishments in the research lab are taking a fast track towards becoming new drugs, so more scientists involved with the development of recombinant DNA drugs are finding it necessary to increase their awareness of existing drug regulations.
