The public health emergency (PHE) is still in effect but the honeymoon has ended. The leniency that the U.S. Food and Drug Administration (FDA) has displayed toward COVID-19 tests and test makers through much of the coronavirus crisis has been replaced with a more business-as-usual approach. Simply stated, the agency is tightening up and increasing regulatory scrutiny over COVID-19 tests, including those that have received Emergency Use Authorization (EUA). No More Mr. Nice Guy Throughout the PHE, FDA officials have insisted that its extensive use of the EUA process and various measures to liberalize rules with regard to pooling, asymptomatic screening, at-home sample collection, non-laboratory setting validation and other aspects of COVID-19 test development and approval represent an expedient to bring desperately needed SARS-CoV-2 diagnostics to market rather than a fundamental change in regulatory approach and philosophy. But as the development of a robust pipeline for new tests obviates the need for flexibility, the agency has signaled its determination to resume normal scrutiny. In a recent interview with Medscape magazine, Dr. Patricia Cavazzoni, Director of the FDA Center for Drug Evaluation and Research (CDER) acknowledged that EUA represents a “different sort of standard when it comes to deciding whether to […]