US Bioresearch Monitoring (BIMO) inspections Guidance released today
Pierre Mermet-Bouvier
eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning
Today, the Draft Guidance for Industry "Processes and Practices Applicable to Bioresearch Monitoring Inspections" was released on FDA web site.
As explained in the background section, "FDA’s BIMO program is a comprehensive portfolio of programs designed to assess and monitor all aspects of the conduct and reporting of FDA-regulated research as well as certain postmarketing activities through on-site inspections, investigations, and Remote Regulatory Assessments (RRAs)".
Compliance programs include Bioavailability-Bioequivalence Studies (Clinical & Analytical), Good Laboratory Practice, Institutional Review Boards, Sponsors and Contract Research Organizations, Clinical Investigators and Sponsor-Investigators...
The 16-page document can be dowloaded at: