"Guidance for Industry, ICH M4: Organization of the CTD"(PDF). 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). August 2001. Archived from the original(PDF) on 8 December 2003.
"Guidance for Industry, ICH M4: Organization of the CTD"(PDF). 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). August 2001. Archived from the original(PDF) on 8 December 2003.