The FDA has issued a final guidance, Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions.
The guidance describes standardized electronic submissions of certain data and information used to plan and conduct BIMO inspections for new drug applications (NDAs), biologics license applications (BLAs) and supplemental applications containing new clinical study reports that are submitted to CDER.
The agency uses the data and information described in this guidance to facilitate the timely identification of sites for inspection and to ensure FDA investigators have the information they need to conduct CDER BIMO inspections. FDA's Bioresearch Monitoring (BIMO) program is designed to monitor all aspects of the conduct and reporting of FDA regulated research.
Sponsors must submit the data in NDAs and BLAs described in this guidance electronically in the format specified in this guidance two years from today. This guidance finalizes the draft guidance issued in February 2018.
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