美国FDA 指导原则 根据FDA现代化法案(FDAMA)为行业和CDRH工作人员提供最终指导的早期协作会议(PDF格式) 英文原版.pdfVIP

Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff Document issued on: February 28, 2001 This document supersedes: Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Guidance for Industry and CDRH Staff, February 19, 1998) U.S. Department of Health and Human Services Food and Drug Administration Center for Dev