FDA Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information
Title:
FDA Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/
Document Type:
Guidance for Industry
Content:
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