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).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.