The US Food and Drug Administration (FDA) has issued two draft guidances on bioresearch monitoring (BIMO) inspections. The first covers information to assist the agency in planning these inspections, while the second 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.
The planning 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…
