About This File
- Docket Number: 98D-0964
- Issued by: Center for Biologics Evaluation and Research
In the Federal Register of July 8, 1997 (62 FR 36558), the Food and Drug Administration announced the availability of Revised Form FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic for Human Use This document provides guidance on the content and format of information to be submitted to the Chemistry, Manufacturing, and Controls (CMC) section and Establishment Description section of a License Application for a biological in vitro diagnostic (IVD) product.