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Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) July 2015 Pharmaceutical Quality/CMC ϲ»¶Ò»µãÒªµãÔÞŶ£¡£¡£¡£¡£¡£¡ |
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