FDA Plans to Complete Hundreds of Delayed BIMO Inspections by Year’s End
The FDA said last week that it plans to gradually resume on-site clinical trial inspections beginning in July with the intent to be back to normal operations by September.
The agency hopes to complete more than 280 domestic clinical investigator and trial site inspections under its Bioresearch Monitoring (BIMO) program before the end of the fiscal year, as it looks to recover from the pandemic-forced slowdown in 2020.
The agency temporarily postponed routine inspections in March 2020, saying it would conduct only inspections it considered mission-critical.
The FDA’s report on inspections shows that the pace of BIMO inspections picked up between October 2020 and March 2021, reaching 236 completed mission-critical inspections, up from 172 mission-critical inspections in the previous six-month period.
The FDA also conducted 29 BIMO priority inspections — certain routine surveillance and for-cause inspections that were not deemed mission-critical by the agency — in the past 12 months; 15 were between March 2020 and September 2020 and 14 between October 2020 and March 2021.
Going forward, the FDA will use a three-tiered system of inspection priority, with Tier 1 covering inspections deemed mission-critical, Tier 2 for higher-priority and Tier 3 for lower-priority inspections. For BIMO, agency crisis or emergency response for-cause work is considered a Tier 1 priority, as are inspections needed for approval for a high-priority product. Tier 2 will apply to BIMO’s prioritized domestic inspections and Tier 3 to routine surveillance inspections.
Read the report here: https://bit.ly/3b8OfCN.