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Guidance for industry M4S, the CTD, safety.

Other Authors: Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.), International Conference on Harmonisation.
Format: Electronic
Language: English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001]
Physical Description: ii, 21 pages : digital, PDF file.
Subjects:
Drug approval -- Government policy -- United States.
Clinical trials -- Reporting -- Government policy -- United States.
Online Access: https://purl.fdlp.gov/GPO/LPS114402
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