FDA Final Guidance on Bioresearch Monitoring Inspections

Detected March 12th, 2026

Summary

The FDA has issued final guidance detailing processes and practices for Bioresearch Monitoring inspections, as mandated by the Food and Drug Omnibus Reform Act of 2022. This guidance outlines record and information requirements, communication best practices, and inspection conduct for regulated entities.

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What changed

The FDA has released final guidance (Docket Number: FDA-2023-D-5021) outlining the processes and practices applicable to Bioresearch Monitoring inspections. This guidance, issued in compliance with the Food and Drug Omnibus Reform Act of 2022, specifies the types of records and information required, best practices for communication between the FDA and industry before and during inspections, and other aspects of inspection conduct. It aims to clarify expectations for entities involved in clinical trials and other research regulated by the FDA.

Regulated entities, including drug manufacturers, pharmaceutical companies, and medical device makers, should review this guidance to ensure their practices align with FDA expectations. While the guidance itself does not impose new legal obligations beyond existing regulations, it clarifies procedural aspects of inspections. The FDA also notes that comments on any guidance can be submitted at any time, though this document is being issued as final.

What to do next

Review the final guidance on Bioresearch Monitoring inspection processes and practices.
Ensure internal procedures for record-keeping and communication during inspections align with guidance recommendations.
Familiarize relevant personnel with best practices for FDA inspections.

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Guidance Documents

Docket Number: FDA-2023-D-5021 Issued by: Guidance Issuing Office Office of Inspections and Investigations Office of the Commissioner, Office of Clinical Policy and Programs Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Center for Devices and Radiological Health Human Foods Program Center for Tobacco Products Center for Veterinary Medicine The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” This final guidance is being issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs the Agency to issue guidance describing the processes and practices applicable to inspections of sites and facilities inspected under FDA’s Bioresearch Monitoring inspection program, to the extent not specified in existing publicly available FDA guides and manuals. The guidance covers the following: the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct.

Submit Comments

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-2023-D-5021.

## Content current as of:

12/19/2025

Regulated Product(s)
- Animal & Veterinary
- Biologics
- Dietary Supplements
- Drugs
- Food & Beverages
- Medical Devices
- Radiation-Emitting Products
- Tobacco
- Vaccines
- Generic Drugs
- Food & Color Additives
- IVDs (In Vitro Diagnostic Devices)