Zdrowie i gospodarka · 08/04/2013

Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Investigational New Drug Applications

The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation to sponsors of investigational new drug (IND) applications to participate in a pilot evaluation program for CBER's eSubmitter Program (eSubmitter). CBER's eSubmitter is a computer-assisted automated program that has been customized to facilitate the creation of IND applications in electronic format, including a template specifically for IND applications related to antivenom drugs/antivenins. Participation in the pilot program is open to sponsors that submit IND applications to the Office of Blood Research and Review, the Office of Cellular, Tissue and Gene Therapy, or the Office of Vaccines Research and Review in CBER. CBER will only accept participation from up to nine sponsors. The pilot program is intended to provide industry and CBER regulatory review staff with an opportunity to evaluate the eSubmitter system and determine if it facilitates the IND submission process. The purpose of this notice is to invite sponsors of IND applications to contact CBER for more information if they are interested in participating in this pilot program.