# Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry - FDA Guidance Document

Source: https://www.keypedia.com/guidances/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/c7353b0c-eb15-4733-80c9-4b757e32acef

> FDA 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. Issue date: December 06, 2024. Get complete insights and analysis.

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## Details

- Title: Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2024-12-06
- Last Changed: 2024-12-09
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-0481">FDA-2018-D-0481</a>

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