# 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 - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/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/9135a75c-48b3-48bb-8340-09e33de8f931

> FDA 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. Issue date: June 05, 2024. Get complete insights and analysis.

---

## Details

- Title: 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
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2024-06-05
- Comment Close Date: 2024-08-05
- Last Changed: 2024-12-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-2221">FDA-2024-D-2221</a>

## Related Documents

- [Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/postapproval-methods-to-capture-safety-and-efficacy-data-for-cell-and-gene-therapy-products-draft-guidance-for-industry/d076649d-1260-49fb-bc96-30f59be10ea0)
- [Potency Assurance for Cellular and Gene Therapy Products](https://www.globalkeysolutions.net/guidances/guidance-document/potency-assurance-for-cellular-and-gene-therapy-products/2a9b0d81-9dd5-43cf-994c-ac0df102c216)
- [Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method](https://www.globalkeysolutions.net/guidances/guidance-document/recommendations-for-the-development-of-blood-collection-processing-and-storage-systems-for-the-manufacture-of-blood-components-using-the-buffy-coat-method/f2f59f9e-1837-4a72-b25b-95ceaa3cdf48)