FDA CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications

May 7, 2025

The Food and Drug Administration issued the final guidance for industry entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions.”  This guidance describes the electronic submission of certain data and information in standardized formats that FDA uses to plan bioresearch monitoring (BIMO) inspections, to facilitate the timely identification of sites for inspection, and to ensure that field investigators from the Agency have the information needed to conduct the inspections.  

The submissions described in the final guidance will be required 24 months after the guidance issued.  As a result of this webinar, sponsors and/or applicants planning to submit new drug applications (NDAs), biologics license applications (BLAs) and NDA or BLA supplements containing new clinical study reports to the Center for Drug Evaluation and Research (CDER) will understand the information they will be required to submit.

Intended Audience

Sponsors and/or applicants planning to submit new drug applications (NDAs), biologics license applications (BLAs) and NDA or BLA supplements containing new clinical study reports to CDER.

Topics Covered:

• Overview of BIMO inspections conducted in support of marketing application review 
• Overview of contents of guidance for industry Standardized Format for Electronic Submission of NDA and BLA Content for BIMO Inspections for CDER Submissions
• Description of the study, site, and subject level information that will soon be required to be submitted in certain NDAs, BLAs, and supplements
• Review of the purpose and general contents of the Bioresearch Monitoring Technical Conformance Guide that should be used in conjunction with the BIMO Guidance.

Resources

• Final Guidance Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry | FDA 
• Bioresearch Monitoring Technical Conformance Guide | FDA   
• For most recent version of the guidance and technical conformance guide check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents  
• Email: [email protected] for specific questions regarding the submissions of BIMO data and information described in this webinar.  

visit the FDA.gov webpage