The FDA has approved the application from Laureate Biopharmaceutical Services for an Electronic Submissions Gateway (ESG) to the agency. The gateway will allow Laureate to offer clients a validated, direct electronic path for IND, NDA and BLA submissions, and builds upon a previous commitment to provide submission-ready CMC documentation for client biological drug substance projects, according to the company. Creation of this electronic new product filing path was spearheaded by Laureate’s...