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

Source: https://www.globalkeysolutions.net/guidances/guidance-document/processes-and-practices-applicable-to-bioresearch-monitoring-inspections-guidance-for-industry/7a35dfcf-1090-49a9-ab18-b2a5b5dfbabc

> FDA guidance document: Processes and Practices Applicable to Bioresearch Monitoring Inspections:  Guidance for Industry. Issue date: December 19, 2025. Get complete insights and analysis.

---

## Details

- Title: Processes and Practices Applicable to Bioresearch Monitoring Inspections:  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: 2025-12-19
- Comment Close Date: 2024-08-05
- Last Changed: 2025-12-18
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-5021">FDA-2023-D-5021</a>

## Related Documents

- [A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/a-risk-based-approach-to-monitoring-of-clinical-investigations-questions-and-answers-guidance-for-industry/3134187f-5a62-4b96-8e62-23b17474de42)
- [Conducting Remote Regulatory Assessments Questions and Answers:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/conducting-remote-regulatory-assessments-questions-and-answers-guidance-for-industry/76800750-6d33-4c38-94de-91b3bda8716d)
- [Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/circumstances-that-constitute-delaying-denying-limiting-or-refusing-a-drug-or-device-inspection-guidance-for-industry/9e51d92c-a107-4e29-ac90-63dedfe2a9c3)
