Apr 7, 2021
The US Food and Drug Administration (FDA) plans to pursue five areas for near-term focus and implementation in terms of improving the agency’s responsiveness to the coronavirus pandemic as well as future public health emergencies.
The latest FDA announcement follows a summary report issued earlier in 2021 on findings of a third-party review of the agency’s pandemic response efforts, the COVID-19 Pandemic Recovery and Preparedness Plan, or PREPP, which was undertaken from July to December 2020.
Based on the summary report findings as well as current FDA priorities and responsibilities, the agency will initially focus on five PREPP-related efforts, including:
Additional summary report pandemic and public health emergency preparedness recommendations that FDA may pursue over the longer term include expanding the depth and breadth of the regulator’s partnerships with other US government agencies such as the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH); establishing an agency-wide approach to supporting innovative clinical trial conduct to benefit both efficient trial execution as well as patient/subject access and experience; and defining a framework utilizing real-world data for post-market surveillance and monitoring of COVID-19 vaccines and therapeutic products.
US FDA may be winding down Emergency Use Authorization (EUA) designations for medical devices and IVDs
The EUA, which covers non-NIOSH-approved disposable filtering facepiece respirators (FFRs) imported from countries other than China, was reissued to eliminate eligibility criteria for approving additional products.