IGF::OT::IGF CERTIFIED GENERIC ENDS FOR CLINICAL RESEARCH PERIOD OF PERFORMANCE 9/1/2015-3/31/2016: BASE AWARD

Investigators

Abstract

This Phase 1 effort demonstrates the technical feasibility of Four Elements Product Development's new Electronic Nicotine Delivery System (ENDS) as a non-commercial standardized generic Research Electronic Cigarette for use in clinical research. Our unique design allows flavorings and constituent levels to be modified by our manufacturing techniques and certified to the Drug Master File (DFM), but not modified by the clinical investigator or the trial subject. This method of configuration and quality control provides the Chemical and Manufacturing Control (CMC) developed and documented in the DMF for use in clinical research testing per FDA standards. Our design includes various user safety features to limit activation time and residue impurity levels.