FDA Approves Use of BD’s HPV Assay with Pap Tests
Becton, Dickinson and Company
Approval expands access to the HPV test that more precisely identifies risk for cervical cancer in patients
FDA
FDA Authorizes Emergency Use Combination Test for Lung Infections
Becton, Dickinson and Company
New single molecular diagnostic test can detect and differentiate multiple respiratory infectious diseases
FDA Proposes New Blood Donor Assessment Model
Swathi Kodaikal, MSc
Most LGBTQ+ advocates welcome FDA’s proposed blood donor eligibility guidance, despite its flaws
FDA: Animal Testing No Longer Mandatory before Human Trials
Swathi Kodaikal, MSc
New FDA law is a “radical shift” in the field of pharmaceutical research and drug development
Medical Community Urging Congress to Remove the VALID Act
Miriam Bergeret, MSc
The VALID Act would block patients from accessing essential diagnostic tests
Authorization of COVID-19 Vaccine for Children under Five Postponed
U.S. Food and Drug Administration
FDA postpones authorization meeting of Pfizer-BioNTech COVID-19 vaccine for children six months through four years old
FDA Grants EUA for CRISPR-Based SARS-CoV-2 Assay
Rachel Muenz
The test aims to help CLIA labs boost testing capacity
FDA Approves Drug to Treat Smallpox
U.S. Food and Drug Administration
New drug approved to help fight the variola virus should the virus be weaponized
Changes to FDA Oversight of Lab-Developed Tests
Kimberly Scott
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
This is the first SARS-CoV-2 diagnostic test permitted to be marketed beyond the public health emergency