FDA'S USE OF INSPECTIONS AND OTHER REGULATORY OVERSIGHT TOOLS DURING COVID-19 AND BEYOND: WELCOME TO THE NEW NORMAL (UPDATED EDITION)

The emergence and persistence of the COVID-19 public health emergency have had a profound effect on the FDA’s regulatory inspections of companies that produce agency-regulated products. Concerns for the safety of FDA investigators as well as the safety of industry personnel prompted months-long postponements of many agency inspections.

However, more profoundly, the COVID-19 emergency has prompted the FDA to evaluate how it can most effectively use the full range of its regulatory authorities and accessible tools and technologies to enhance its inspectional capacity, including remote interactive evaluations and remote regulatory assessments.

This evaluation is likely to have a critical impact on the relationship between FDA-regulated companies and the agency. While in the past FDA surveillance has most visibly taken the form of on-site inspections, companies may see the agency’s increasing use of these authorities, tools and technologies to determine a company’s compliance with FDA requirements. And the changes are likely to continue far beyond the course of the pandemic.

This white paper by Thompson FDA recounts the pandemic’s effect on the agency’s inspectional program and offers a detailed view of how the FDA’s use of surveillance tools beyond on-site inspections may affect agency-regulated companies — and how those companies can best prepare for this emerging new era of FDA regulatory oversight.