For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry

Issue Date: May 10, 1999
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood, Blood Products
Status: Final

For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry

In the Federal Register of July 8, 1997 (62 FR 36558), the Food and Drug Administration (FDA) announced the availability of Revised Form FDA 356h, “Application to Market a New Drug, Biologic, or an Antibiotic for Human Use.”3, 5 This document provides guidance on the completion of this form and the content and format of the Chemistry, Manufacturing, and Controls (CMC) section and the Establishment Description section of a License Application for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture. For these products, FDA is now implementing the BLA (revised Form FDA 356h) and will accept biologics license applications instead of two separate license application submissions, the product license application (PLA) and the establishment license application (ELA).

Download the Guidance Document