FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends
Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.
FDA-nir
Subscribe today for access to
Articles and Reports
Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits
At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.
FDA Tightens the Screws on EUA Review of COVID-19 Tests
The agency recently announced subtle but significant changes to its policies governing review of new lab tests for COVID-19.
FDA Grants Approval for 23andMe DTC Genetic Test
From - National Intelligence Report
23andMe and the U.S. Food and Drug Administration (FDA) announced last week that the agency allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for…
Flu Antigen Tests Reclassified as Class II Devices
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Discussion Paper Synthesizes Stakeholder Feedback on LDT Regulation
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Synthesizes Feedback on LDTs in New Discussion Paper
From - National Intelligence Report
Following up its decision not to issue final guidance in 2016 regarding oversight of laboratory developed tests (LDTs), the U.S. Food and Drug Administration released a…
No Final LDT Framework in 2016: FDA Seeks Further Input from Stakeholders, New Administration
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Won’t Release Final LDT Guidance in 2016
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) has provided laboratories with some much needed good news—the agency will not finalize its…
CDC and the Diagnostics Industry Continue to Battle Zika
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Recommendation Against Ovarian Cancer Screening
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Considers Liquid Biopsies
From - National Intelligence Report
In addition to laboratory developed tests and next generation sequencing, could the FDA be looking to impose standards or guidance governing use of…
Public Comment Sought on Blood Donor Deferral Policies to Reduce HIV Transmission
From - National Intelligence Report
While the annual rate of new diagnosed cases has declined in the last 10 years, HIV still remains a significant concern. The Centers for Disease Control and Prevention (CDC) reports…