FDA Approves Drug to Treat Smallpox
U.S. Food and Drug Administration | June 8, 2021
New drug approved to help fight the variola virus should the virus be weaponized
FDA
Changes to FDA Oversight of Lab-Developed Tests
Kimberly Scott | May 5, 2021
The decision to revoke FDA oversight of LDTs is no longer clear after HHS removed its initial statement
FDA Permits Marketing of First COVID-19 Diagnostic Test via De Novo Process
U.S. Food and Drug Administration | March 19, 2021
This is the first SARS-CoV-2 diagnostic test permitted to be marketed beyond the public health emergency
New Study Identifies Top-Performing Point-of-Care COVID-19 Tests
NSF International | February 9, 2021
Researchers screen rapid-detection COVID-19 tests for sensitivity/specificity, limit of detection, and time to results
FDA Approves Emergency Use Authorization for Moderna's Coronavirus Vaccine
Moderna, Inc. | December 18, 2020
The US FDA Advisory Committee voted unanimously to approve emergency use of Moderna’s COVID-19 vaccine