FDA Guidance Addresses Bioresearch Monitoring Program

Bioresearch monitoring inspections described in the guidance can apply to panel track and 180-day supplements, which normally include clinical and non-clinical information. The guidance doesn't apply to real-time supplements, which don't have bioresearch monitoring inspections, or to 30-day notices, 135-day supplements, special PMA supplements, express supplements, and PMA annual reports.

In a question and answer format, the guidance explains the bioresearch monitoring process, detailing the steps and entities involved in the review process. It also explains how the bioresearch monitoring inspection results affect application approvals. Very infrequently, according to the guidance, such inspections may reveal problems with data that justify a deficiency letter that requires additional information be submitted or an Application Integrity Policy Letter that requires an audit and corrective action plan. The guidance describes the timing of the inspection process, which can take up to 90 days.

Finally, the guidance explains what can delay the process, including simple omissions of contact information or copies of informed consent documents to unavailability for the bioresearch monitoring inspection. The guidance warns that sites outside the United States can raise privacy issues with regard to review of data and sponsors should ensure the FDA will have access to data needed during the inspection.