The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections” and also released draft guidance "Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions" for comments.
Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research.
These are inspections conducted by the FDA to oversee the conduct of clinical trials and ensure compliance with regulatory requirements. The main objectives are to verify the accuracy and reliability of data, ensure the safety and welfare of trial participants, and assess the adherence to Good Clinical Practice (GCP) guidelines.
FDA is issuing this draft guidance to describe the processes and practices applicable to inspections of sites and facilities inspected under the agency's Bioresearch Monitoring inspection program, to the extent not specified in publicly available FDA guides and manuals. This guidance describes the types of records and information that need to be provided, best practices for communicating between the FDA and industry prior to or during an inspection, as well as other inspection-related practices.
The BIMO inspections typically include:
Inspections supporting FDA's review of specific submissions or marketing applications.
Periodic inspections of establishments with ongoing activities, such as nonclinical laboratories or institutional review boards (IRBs).
Inspections to assess potential noncompliance or safety issues reported in complaints or required reports from IRBs or sponsors.
These inspections can be comprehensive, covering all operations, or directed, focusing on specific operations.
Guidance: Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections
This draft guidance applies to the electronic submission of data and information from major (i.e. pivotal) studies used to support safety and efficacy claims in biologics license applications (BLAs) and new drug applications (NDAs) regulated by the Center for Biologics Evaluation and Research (CBER), including supplemental applications containing new clinical study reports.
Also, it applies when these data and information are included in certain investigational new drug applications (INDs) before a BLA, NDA, or supplemental application is submitted. When this draft guidance is finalized, it will include the same data and information requirements in CDER's draft Standardized Format for Electronic Submission of NDA and BLA Content for BIMO Inspection Planning Guidance for Industry.
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