Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product: Guidance for Industry

Issue Date: January 5, 1999
Issued by: Center for Biologics Evaluation and Research
Topic(s): Vaccines
Status: Final

Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product: Guidance for Industry

In the Federal Register of July 8, 1997, 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 the Chemistry, Manufacturing, and Controls (CMC) and Establishment Description sections of a License Application for a vaccine or related product. Reagents for in vitro diagnostic use are outside the scope of this document

Download the Guidance Document