biological products / eCTD Web site / eCTD web page / biological product / guidance Web page / cellular and tissue-based products / /
OperatingSystem
OSE / /
Organization
U.S. Department of Health and Human Services / Congress / Food and Drug Administration Center for Drug Evaluation and Research / office of Surveillance and Epidemiology / office of Compliance / FDA / office of Communication / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / CDER office of Surveillance and Epidemiology / office of Communications Division of Drug Information / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / / /
Guidance for Industry Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers U.S. Department of Health and Human Services