Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use.'' This guidance document was prepared by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). On May 14, 1996, FDA published a final rule that amended the biologics regulations to eliminate the establishment license application (ELA) for manufacturers of certain products. Instead, a sponsor may submit a biologics license application that includes a chemistry, manufacturing, and controls (CMC) section. This guidance document is intended to assist applicants in the preparation of the CMC information for marketing applications for certain specified products, including therapeutic recombinant deoxyribonucleic acid (DNA)-derived products or monoclonal antibody products for in vivo use, as well as those recombinant DNA-derived products regulated using a new drug application submitted to CDER.