What The FDA’s Inspections Q&A Guidance Really Means: It’s Time To Offer Virtual Inspections

What The FDA’s Inspections Q&A Guidance Really Means: It’s Time To Offer Virtual Inspections

August 25, 2020, The Pink Sheet

Tom Cosgrove is quoted in The Pink Sheet regarding virtual inspections conducted by the FDA during the COVID-19 pandemic. Mr. Cosgrove says, “We were hoping to see some progress on remote or virtual facility inspections.”

He notes that the agency has been working hard to avoid the need for pre-approval inspections by, for example, requesting records and talking more with sponsors and foreign regulators. But for some sites, the agency finds it has no other choice but to conduct an in-person inspection.

"For facilities in COVID hotspots and foreign countries, this means that applications could be sitting for a long, long time before approval," he adds. “Hopefully, FDA will join with other regulators around the world and start doing true virtual inspections soon.”

Mr. Cosgrove sees a need for more information than the Q&A document provides. He says the good news is that when there is no information about a site that cannot be inspected, "the agency will simply blow the PDUFA date and not issue a complete response letter.”

The problem is the lack of clarity on just what sort of negative information could be so concerning that it would lead the agency to issue a complete response letter. "Does this mean a prior bad inspection?  Concerns raised by foreign regulators?  An anonymous complaint?  We're hoping that FDA spells out more what that means," he adds.