The Food and Drug Administration has not proposed new regulations governing products of biotechnology. However, experience gained in this burgeoning industry has necessitated a refinement of specific Investigational New Drug (IND) requirements. Unlike conventional small molecules, the complex proteins of biotechnology are defined by both analytical data and method of manufacture. The informational requirements of the manufacturing and controls sections of the IND are discussed in the context of an assurance of product safety.
Coordinated Framework for Regulation of Biotechnology.Fed Reg. 1986;51(123):23302–23350.
2.
Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals; Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use; Points to Consider in the Manufacture of In Vitro Monoclonal Antibody Products Subject to Licensure; Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology; Interferon Test Procedures: Points to Consider in the Production and Testing of Interferon Intended for Investigational Use in Humans. Rockville, MD: Center for Biologics Evaluation and Research, FDA.
3.
New Drug, Antibiotic, and Biologic Drug Product Regulations; Final Rule. Fed Reg. 1987;52(53):8798–8847.
