# Processes and Practices Applicable to Bioresearch Monitoring Inspections: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/processes-and-practices-applicable-to-bioresearch-monitoring-inspections-draft-guidance-for-industry/de2847ff-8b71-474f-8e61-87ff7e13dde9

> FDA guidance document: Processes and Practices Applicable to Bioresearch Monitoring Inspections: Draft Guidance for Industry. Issue date: June 05, 2024. Get complete insights and analysis.

---

## Details

- Title: Processes and Practices Applicable to Bioresearch Monitoring Inspections: Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: veterinary
- Office Name: Office of Inspections and Investigations
- Office URL: /offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8
- Issue Date: 2024-06-05
- Comment Close Date: 2024-08-05
- Last Changed: 2024-10-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-5021">FDA-2023-D-5021</a>

## Related Documents

- [Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/standardization-of-data-and-documentation-practices-for-product-tracing-guidance-for-industry/d58db3d4-b065-42bd-88a6-e18fe6db0a51)
- [Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products:  Nonclinical Information](https://www.globalkeysolutions.net/guidances/guidance-document/generally-accepted-scientific-knowledge-in-applications-for-drug-and-biological-products-nonclinical-information/80a1d387-00c7-42b3-90ef-982941cdff8b)
- [Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document](https://www.globalkeysolutions.net/guidances/guidance-document/combined-food-and-drug-administration-and-sponsor-oncologic-drugs-advisory-committee-briefing-document/acf14472-e5b8-47ba-a5bd-76d6bae8bd27)
