Issue Date: May 1, 2001
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Final
IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information: Guidance for Industry
This document provides guidance to industry on formal meetings between sponsors of investigational new drug applications (INDs) and the Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) on chemistry, manufacturing, and controls (CMC) information. This guidance applies to INDs for human drugs and biologics (referred to as drugs).
Download the Guidance Document
