Julie Tibbets

Jul 26, 2024 | today.westlaw.com | Julie Tibbets

Enter to open, tab to navigate, enter to select

Jul 25, 2024 | jdsupra.com | Julie Tibbets

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research. As a follow up to our July 2023 post, we highlight the most common violations identified in Fiscal Year (FY) 2023, in addition to those observed thus far in FY 2024. BIMO conducted 1073 inspections in FY 2023.

Jul 25, 2024 | mondaq.com | Julie Tibbets

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research. As a follow up to our July 2023 post, we highlight the most common violations identified in Fiscal Year (FY) 2023, in addition to those observed thus far in FY 2024. BIMO conducted 1073 inspections in FY 2023.

Jun 10, 2024 | mondaq.com | Julie Tibbets

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best practices for responding to Form FDA 483s, albeit in the context of its Bioresearch Monitoring (BIMO) program inspections, but very much translatable to any Form FDA 483 response.

Jun 5, 2024 | jdsupra.com | Julie Tibbets

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best practices for responding to Form FDA 483s, albeit in the context of its Bioresearch Monitoring (BIMO) program inspections, but very much translatable to any Form FDA 483 response.