Regulating recombinant DNA biologics.

M L Crouch

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PubMed · 3207440

Regulating recombinant DNA biologics.

M L Crouch

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Abstract

Biologics have been regulated in the United States since 1902. Many new products and technologies have been introduced since that original Act defined a biologic and specified how they should be controlled. Fortunately, that authorizing authority, now known as Section 351 of the Public Health Service Act, proved to be flexible enough to provide adequate assurance of the safety, purity, and efficacy of these new products, with minimal promulgation of regulations. The new biotechnology products, although presenting a challenge, are being regulated consistent with our policy for all other biologics. The scientific advances now possible because of recombinant DNA technology are seeming unlimited. Safety issues resulting from the use of such products are examined. These issues include: a) alterations in molecular structure; b) chemical and physical alterations; and c) purity standards of final products. Lastly, strategies that have been developed for regulating these biotechnical products, within the framework of FDA statutes and regulations are reviewed.

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Biotechnology DNA, Recombinant Legislation, Medical United States United States Food and Drug Administration Journal Article

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M L Crouch. 1988. Regulating recombinant DNA biologics.. https://pubmed.ncbi.nlm.nih.gov/3207440/

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