(Reuters) – The U.S. Food and Drug Administration’s decision to repeatedly modify its emergency use authorization policies to increase availability of COVID-19 tests during the early phase of the pandemic led to quality control issues, according to a federal agency review.
FDA’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, according to a review conducted by the U.S. HHS’s Office of Inspector General.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Shailesh Kuber)