FDA - Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of BIMO Inspections

6th June 2024

FDA

Standardised 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This draft guidance applies to electronic submissions of data and information from the major (i.e., pivotal) studies  used to support safety and efficacy claims in biologics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. 

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