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GUIDANCE DOCUMENT

Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry December 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2018-D-0481
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or the Agency) is announcing the availability of the guidance for industry entitled "Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions." This guidance describes the electronic submission of certain data and information in standardized formats. This information is used by the Center for Drug Evaluation and Research (CDER) in the planning of, and by FDA’s Office of Inspections and Investigations (OII) in the conduct of, BIMO inspections.

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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-2018-D-0481.

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