CBER electronic submissions
This article was originally published in The Gray Sheet
Executive Summary
Guidance document on voluntary electronic-format regulatory submissions to FDA's Center for Biologics Evaluation and Research is released Nov. 12. The document represents the agency's attempt to develop an efficient process for the electronic submission of regulatory information for biologics license applications (BLAs), product license applications (PLAs)/establishment license applications (ELAs) and new drug applications (NDAs). Written comments may be submitted "any time," FDA says