ICH eCTD Implementation Working Group / M2 eCTD Implementation Working Group / /
Country
Japan / United States / /
Event
FDA Phase / /
Facility
Rockville Pike / /
IndustryTerm
biological products / /
Organization
U.S. Department of Health and Human Services / HFD-240 Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / Food and Drug Administration Center for Drug Evaluation and Research / Training and Communication Division of Drug Information / Food and Drug Administration / ICH Steering Committee / Center for Biologics Evaluation and Research / office of Training / Center for Biologics Evaluation and Research Food and Drug Administration / office of Communication / Training and Manufacturers Assistance / / /
Guidance for Industry M2: eCTD Specification Questions & Answers and Change Requests