FDA Releases Draft Guidance on BIMO Inspection Submission Requirements

Sponsors submitting NDA and BLA content for bioresearch monitoring inspections should list all relevant clinical sites and entities responsible for clinical study-related activities, according to new draft guidance from the FDA on standardized formatting for BIMO inspection submissions.

The agency conducts BIMO inspections to ensure the protection of research subjects and the integrity of data submitted in support of marketing applications.

The submissions must include a comprehensive table listing all clinical sites participating in clinical studies, as well as accurate contact information for the sites, including the name of each site’s clinical investigator, its identification number and address, as well as any applicable updates to clinical investigators’ contact information, the agency said.