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GUIDANCE DOCUMENT

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 June 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-2221
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This draft guidance applies to electronic submissions of data and information from the major (i.e., pivotal) studies  used to support safety and efficacy claims in biologics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  This draft guidance, when finalized, will contain the same data and information requirements described in the Center for Drug Evaluation and Research (CDER) draft Standardized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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-2221.

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