FDA is increasing its pressure on sponsors to conduct pre-market human factors (HF) studies for combination products, including pre-filled syringes, and industry is getting clearer on the agency’s expectations as more experience is gained.
At the American Association of Pharmaceutical Scientists (AAPS) National Biotech Conference in late May in San Diego, California, Douglas Mead, the Regulatory Affairs CMC Director for Medical Device and Combination Products at Janssen Biologics, confirmed that the Center for Drug Evaluation and Research (CDER) is now “requiring formal summative human factors studies for most delivery devices.” CDER, he added, is requesting that human factor study protocols be “sent in for review prior to implementation.”
Human factors/usability analysis has been gaining prominence in the dialogue between combination product manufacturers and regulators. At issue is an effective pathway for companies to follow in conducting and submitting the analysis and for regulators to follow in reviewing it. (See IPQ “The News in Depth” April 12, 2011. The story includes insights by Center for Devices and Radiological Health (CDRH) Office of Device Evaluation (ODE) Ron Kaye, who leads the office’s Human Factors and Device Use Safety Team.)
At the AAPS meeting, Mead discussed the experience Janssen and other firms are gaining regarding: ● what information the agency is looking for, when it is required and in what form ● general study requirements ● expectations for Phase III clinical trials, and ● challenges posed by biologics when conducting human factor studies.