CDER: eSubmissions Were Missing From Bioresearch Monitoring System

Drug industry stakeholders using the FDA’s Bioresearch Monitoring Information System (BMIS) to analyze clinical research trends may not have been getting as accurate a picture as they thought. The publicly searchable database is missing clinical investigator information from investigational new drug (IND) studies that were submitted in electronic format, CDER said in a recent notice to industry.
Clinical Trials Advisor