If we as an industry learn from fighting the COVID-19 pandemic, David Burrow, PharmD, JD, Director of the Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA) He has something high on his wish list. “I hope we see the need to build quality into clinical research, from concept to operation,” says Burrow.
“The pandemic has shown the need for training and a focus on good clinical practice, not just for ideal situations but also for situations where things are going sideways,” adds Burrow, who has insights into how to deal with the FDA Form 483 will be giving (inspection observations) and Warning Letters, along with shout-outs, to its FDA colleagues for their good work in a meeting for the ACRP 2021 virtual conference in September.
“The FDA inspectors’ work during the pandemic has been phenomenal,” said Burrow, noting how they helped avert “a potentially catastrophic slowdown” in inspections and the entire drug approval process.
CDER BIMO Compliance and Enforcement – What You Need To Know!
Visit Burrow on Thursday, September 16, during the third and final edition of ACRP 2021 to explore how the clinical research industry can make the FDA inspection experience positive. Bring practical approaches to working with the FDA during an inspection, respond to 483s after an inspection, and respond to subsequent regulatory correspondence.
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Burrow also welcomes the results of an FDA’s Resiliency Roadmap for FDA Inspectional Oversight report released in May, which outlines the agency’s inspection activities during the COVID-19 pandemic and its detailed plan to achieve more consistent operational status.
“Like most organizations around the world, the FDA faced unprecedented and unique challenges during the SARS-CoV-2 pandemic. In particular, our inspection, monitoring and compliance activities have been severely impacted, ”said Acting FDA Commissioner Janet Woodcock, MD, at the release of the report. “The FDA is fully aware of the importance of a more consistent inspection capacity. This plan provides the public with a transparent picture of both the successes and challenges we have faced in these areas over the past year and our future plan. We want to reassure the American public that we have used a variety of tools to oversee the regulated industry and ensure Americans continue to have access to safe food and high quality FDA regulated products. “
However, it’s not just the pandemic that has challenged the clinical trial industry, adds Burrow. He mentions staff shortages and high fluctuation rates in some areas of the clinical study company as potential obstacles. “ACRP’s“ Partner in Workforce Advancement ”initiative has been making this important point clear for some time,” says Burrow, a member of the initiative’s executive committee. Given the trends in staff turnover, Burrow believes that education and training programs like the ACRP 2021 virtual conference are more important than ever as new attendees need to learn how to best conduct high quality clinical trials.
However, if many things have changed since the pandemic turned the clinical trial industry on its head, Burrow can point to one area that hasn’t changed an iota: the importance of timely responses to FDA Form 483s and Warning Letters. “COVID has not changed that at all,” he says.
Author: Michael Causey