Partner Kathleen Sanzo spoke at a recent Food and Drug Law Institute (FDLI) event, discussing how the US Department of Justice’s (DOJ’s) Consumer Protection Branch works with the US Food and Drug Administration (FDA) to investigate civil and criminal matters involving misbranded products.
Medtech Insight’s coverage of the FDLI event reported Kathleen explaining that the clinical trial landscape is under increasing FDA scrutiny. More trials are being conducted now than in the past, and because companies are struggling to recruit patients, technologies to expedite patient recruitment are being developed. Some of those efforts may not be “well founded,” Kathleen said.
“It’s not a COVID-[19] related issue.”
“It’s just the proliferation of clinical trial trials and the need for research and development around tracking device products, and I think you're going to continue to see issues there.”
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