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GUIDANCE DOCUMENT

Processes and Practices Applicable to Bioresearch Monitoring Inspections Draft Guidance for Industry June 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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

Docket Number:
FDA-2023-D-5021
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
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
Center for Food Safety and Applied Nutrition
Center for Tobacco Products
Center for Veterinary Medicine

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.”  The draft guidance is being issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs the Agency to issue guidance describing the processes and practices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  The draft guidance is intended to cover the following: the types of records and information required to be provided, best practices for communication between FDA and industry in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.

 
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