Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions

Issue Date: June 5, 2024
Issued by: Center for Biologics Evaluation and Research
Topic(s): Electronic Submissions,
Status: Draft

Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions

This draft guidance applies to electronic submissions of data and information from the major (i.e., pivotal) studies  used to support safety and efficacy claims in biologics license applications (BLAs) and new drug applications (NDAs) regulated by the Center for Biologics Evaluation and Research (CBER), as well as supplemental applications containing new clinical study reports.  It also applies when these data and information are submitted in certain investigational new drug applications (INDs)  in advance of a planned BLA, NDA, or supplemental submission.  This draft guidance, when finalized, will contain the same data and information requirements described in the Center for Drug Evaluation and Research (CDER) draft Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry, when finalized.

Download the Guidance Document