Federal investigators recommend changes to FDA’s EUA policy for tests

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Federal investigators recommend changes to FDA’s EUA policy for tests

Sept 21 (Reuters) – Federal investigators on Wednesday recommended that the U.S. Food and Drug Administration revise its emergency use authorization (EUA) policies for tests to ensure better availability and quality during future infectious disease outbreaks.

The recommendations were made by the Office of Inspector General at the Department of Health and Human Services after conducting a review of FDA’s EUA activities and decision making for COVID-19 tests in the early months of the pandemic.

The drug regulator’s policies allowed diagnostic and serology tests to get on the market quickly; however, that resulted in some problematic tests on the market, according to the OIG report.

The review’s findings, which were published on Wednesday, highlight that regulator’s decision to accept all EUA requests resulted in a record number of submissions – often low-quality and from developers lacking experience with FDA’s processes.

The recommendations include revision of FDA’s EUA submission policy, expansion and improvement of resources for test developers, better communication between the regulator and lab community, and developing a national testing strategy that goes beyond the EUA process.

The OIG is an internal watchdog office tasked with rooting out waste, fraud and abuse.

Reporting by Mrinalika Roy in Bengaluru; Editing by Shailesh Kuber

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Source: Reuters