Electronic Investigational New Drug Application: Cumulative Table of Contents; Public Meeting

Samenvatting

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the possibility of using extensible markup language (XML) to create a cumulative table of contents for investigational new drug applications (IND's) intended to be submitted electronically to the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER). Although the agency does not yet have a comprehensive approach to accepting IND's in electronic format in place of paper, it is updating existing guidance to make electronically submitted IND's in place of paper possible in the future. The agency is hoping to gain public input at the meeting on the use of XML to create a cumulative table of contents.