Authorization of COVID-19 Vaccine for Children under Five Postponed
U.S. Food and Drug Administration | Feb 14, 2022
FDA postpones authorization meeting of Pfizer-BioNTech COVID-19 vaccine for children six months through four years old
FDA
FDA Grants EUA for CRISPR-Based SARS-CoV-2 Assay
Rachel Muenz | Feb 10, 2022
The test aims to help CLIA labs boost testing capacity
FDA Approves Drug to Treat Smallpox
U.S. Food and Drug Administration | Jun 08, 2021
New drug approved to help fight the variola virus should the virus be weaponized
Changes to FDA Oversight of Lab-Developed Tests
Kimberly Scott | May 05, 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 | Mar 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 | Feb 09, 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. | Dec 18, 2020
The US FDA Advisory Committee voted unanimously to approve emergency use of Moderna’s COVID-19 vaccine