Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold.

Abstract

BACKGROUND The Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) receives about 1500 initial Investigational New Drug applications (INDs) per year. In the first 30 days after initial IND submission, FDA conducts a review to determine whether the proposed investigation is safe to proceed, and if not, the IND may be placed on… (More)
DOI: 10.1136/jim-2015-000010

Topics

Figures and Tables

Sorry, we couldn't extract any figures or tables for this paper.

Slides referencing similar topics