FDA Bioresearch Monitoring Inspections Increase in 2014

The FDA saw the number of bioresearch monitoring inspections increase 11 percent in fiscal year 2014, to 1,136 from 1,019 in 2013.

Of those, CDER conducted 121 BIMO inspections and CBER conducted 675 — up from 104 and 524, respectively.

Most of the observations didn’t require any specific action, with 58 percent classified “no action indicated” in 2014, compared with 56 percent the previous year. Observations prompting official action fell to 37 percent last year from 42 percent in 2013.

Sponsors were faulted mainly for inadequate monitoring, failing to bring investigators into compliance, inadequate accounting for study drugs and failing to get FDA or IRB approval prior to commencing studies.

John Avellanet, managing director and principal consultant at Cerulean Associates, says the data reflect former FDA commissioner Margaret Hamburg’s reorganization of the agency to focus on premarket and postmarket surveillance inspections rather than routine inspections.

Over the next four to five years, companies will need to continue beefing up their clinical quality management and data integrity control systems, he says. Ultimately, this could mean fewer product liability lawsuits.

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