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FDA issues draft guidances covering BIMO inspections (Catapult’s regulatory round-up – June 2024)

The FDA has issued two draft guidances on bioresearch monitoring (BIMO) inspections.

The first draft guidance entitled ‘Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions’ covers information to assist the agency in planning these inspections. This guidance should be read in conjunction with the BIMO technical conformance guide issued in August 2022, which covers the specifications for preparing and submitting clinical study information and subject-level data line listings by clinical sites.

The second draft guidance entitled ‘Processes and Practices Applicable to Bioresearch Monitoring Inspections Guidance for Industry’ covers best practices for communicating to the FDA before, during, or after an inspection.

Both cover sponsors that have submitted new drug applications (NDAs), biologics license applications (BLAs), and supplements.

Published on the 3rd of July in Catapult’s regulatory round-up for June 2024.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA issues draft guidances covering BIMO inspections (Catapult’s regulatory round-up – June 2024). ELSIBI. Consulté le 25 avril 2025 à l’adresse https://doi.org/10.58079/12mj6


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