FDA Will Continue “Hybrid” Clinical Trial Inspection Approach

Elizabeth Miller, FDA Assistant Commissioner for Medical Products and Tobacco Operation, Office of Regulatory Affairs

Clinical trial entities should expect the U.S. Food and Drug Administration (FDA) to maintain its usage of “hybrid” inspection tools and tactics, Elizabeth Miller, the agency’s assistant commissioner for medical products and tobacco operation in the Office of Regulatory Affairs, said at the WCG-FDAnews’ FDA Inspections Summit yesterday (November 16).

Calling it “the new normal,” Miller said the agency would continue to employ a mix of remote record monitoring and onsite physical inspections, especially in the case of international inspections. She also noted remote inspections actually often take more time than physical inspections, both for the FDA inspector and the regulated entity.

Remote inspections can require more record-collection effort, Miller noted. Other obstacles include technological limitations and time zone challenges for inspection work done remotely.

However, Miller was upbeat about the value of hybrid inspections and lauded the agency for its success with them during the COVID-19 pandemic. “I’m very proud” the FDA conducted 25 COVID-19 vaccine-related inspections and six COVID-19 therapeutic inspections during a period of four weeks last year, she said.

“We’ve had to adjust and transform how we work,” said Miller. “We’ve had to be more agile than ever before, and we’re committed to moving forward with this mindset.”

Author: Michael Causey