Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products.'' This guidance, prepared by the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Devices and Radiological Health, is intended to assist applicants in the preparation of the chemistry, manufacturing, and controls (CMC) section and the establishment description section of a biologics license application (BLA) or in the preparation of a product license application (PLA) and establishment license application (ELA) for all autologous somatic cell therapy products. This guidance may assist in complying with certain requirements in the Code of Federal Regulations.