title: Regulating recombinant DNA biologics.
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.
authors.affiliation: Department of Health and Human Services, Food and Drug Administration, Rockville, MD.
authors.forename: M L
authors.initials: ML
authors.lastname: Crouch
mesh_terms: D001709:Biotechnology / Q000592:standards*; D004274:DNA, Recombinant; D007883:Legislation, Medical; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004274:DNA, Recombinant