> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Stakeholder Comments on FDA BIMO Guidance
- URL: https://www.fdaweb.com/stakeholder-comments-on-fda-bimo-guidance/
- Published: 2024-08-08T12:00:00.000Z
- Updated: 2026-09-14T14:37:49.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5157530

AdvaMed says it supports FDA’s long-standing bioresearch monitoring (BIMO) program and the provision of the FDA Omnibus Reform Act of 2022 that codified the program into law. In its [comment](https://www.regulations.gov/comment/FDA-2023-D-5021-0013?ref=fdaweb.com) on an FDA draft guidance on BIMO inspection processes and practices, AdvaMed says the agency should clarify that read-only access to electronic systems will only be used for on-site inspections. “Many of the documents shared with FDA during a BIMO inspection are highly confidential and may contain health and other extremely sensitive data,” the association says. “This concern is particularly acute in the remote environment.”

In its [response](https://www.regulations.gov/comment/FDA-2023-D-5021-0011?ref=fdaweb.com), Genentech notes a lack of information about how FDA plans to modernize, optimize, and streamline its approach to inspections. “Specifically,” it says, “we encourage FDA to leverage modern tools and technologies for the planning, conduct, and reporting of inspections under this program.” The company says that would include incorporating all available information on good clinical practice compliance into risk-based decision-making on inspection scope and objectives, and incorporating remote and hybrid approaches to conducting inspections.

Specific line-by-line comments were submitted by [Sanofi](https://www.regulations.gov/comment/FDA-2023-D-5021-0014?ref=fdaweb.com) and the [Parenteral Drug Association](https://www.regulations.gov/comment/FDA-2023-D-5021-0010?ref=fdaweb.com).