FDA: S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

This guidance is intended primarily to recommend a basic framework for the preclinical safety evaluation of biotechnology-derived pharmaceuticals. It applies to products derived from characterized cells through the use of a variety of expression systems including bacteria, yeast, insect, plant, and mammalian cells. The intended indications may include in vivo diagnostic, therapeutic, or prophylactic uses. The active substances include proteins and peptides, their derivatives, and products of which they are components; they could be derived from cell cultures or produced using recombinant deoxyribonucleic acid (DNA) technology, including production by transgenic plants and animals. Examples include but are not limited to: Cytokines, plasminogen activators, recombinant plasma factors, growth factors, fusion proteins, enzymes, receptors, hormones, and monoclonal antibodies.