domingo, 4 de octubre de 2020

A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response | FDA

A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response | FDA

illustration of people wearing face masks and spraying disinfectant to protect against the spread of the coronavirus and numbers marking efforts made by FDA/CDRH from 1/1/2020 to 9/18/2020 to fight the spread of the coronavirus: 23 guidance documents; 10 EUA templates; 1,734 Pre-EUAs; 3,040 EUAs; 516 Medical Devices; 248 Tests; Outreach to 1,000+ manufacturing sites; 58 CDRH Commissioned Corps officers deployed 78 times; 13.7M emails; 39 COVID-related webinars with 36,000+ participants

By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs
If you want to know the U.S. Food and Drug Administration’s impact on COVID-19, look no further than the numbers. In a few short months, the agency’s Center for Devices and Radiological Health’s (CDRH) response to the pandemic has been unprecedented in terms of volume, speed, and agility – spanning multiple areas, including: regulatory flexibility, Emergency Use Authorizations (EUAs) for devices, shortage mitigation activities, Public Health Service Corps deployment, and extensive engagement with stakeholders. Additionally, over 50 percent of CDRH employees have dedicated an incredible number of hours to the COVID-19 response, in addition to performing their existing responsibilities at the FDA.
Commisioner Dr. Hahn
As we grapple with COVID-19, the echoes of the 1918 pandemic ring loud and clear. Although that virus infected more than 500 million people – or one-third of the world’s population – and killed 675,000 Americans, modern day travel has made the potential of this pandemic very concerning. As we grapple with COVID-19, the echoes of the 1918 pandemic ring loud and clear. Although that virus infected more than 500 million people – or one-third of the world’s population – and killed 675,000 Americans, modern day travel has made the potential of this pandemic very concerning. [9/29/2020]    

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