Clinical trial companies should expect the US Food and Drug Administration (FDA) to maintain their use of “hybrid” inspection tools and tactics, said Elizabeth Miller, deputy commissioner for medical devices and tobacco operations in the Office of Regulatory Affairs at The FDA inspection summit from WCG-FDAnews yesterday (November 16).
Calling it “the new normal,” Miller said the agency will continue to use a mix of remote record monitoring and physical on-site inspections, especially during international inspections. She also noted that remote inspections are often more time consuming than physical inspections, for both the FDA inspector and the regulated company.
Remote inspections can require more effort to collect records, Miller noted. Other obstacles include technology constraints and time zone challenges for inspection work that is performed remotely.
However, Miller was optimistic about the value of hybrid inspections and praised the agency for its success with them during the COVID-19 pandemic. “I’m very proud” that the FDA conducted 25 COVID-19 vaccine inspections and six therapeutic COVID-19 inspections over a four-week period last year, she said.
“We had to adapt and change the way we work,” Miller said. “We had to be more agile than ever, and we are determined to move forward with that mindset.”
Author: Michael Causey