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Guidance for Industry
M4Q: The CTD — Quality
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
August 2001
ICH
Guidance for Industry
M4Q: CTD — Quality
Additional copies are available from:
Office of Training and Communications
Division of Drug Information HFD-240
5600 Fishers Lane
Rockville, MD 20857
(Tel) 301-827-4573
(Internet) /cder/guidance/index.htm
or
Office of Communication, Training and
Manufacturers Assistance, HFM-40
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448
Internet: /cber/guidelines.htm.
Fax: 1-888-CBERFAX or 301-827-3844
Mail: the Voice Information System at 800-835-4709 or 301-827-1800 .
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
August 2001
ICH
TABLE OF CONTENTS
BACKGROUND 2
The CTD 2
Preparing and Organizing the CTD 2
Module 4. Nonclinical Study Reports 3
Organization
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