FDA Stepping Up Actions Against PGx Testing, Forcing Some Labs to Stop Reporting Drug Information

Aug 16, 2019

|

NEW YORK – The US Food and Drug Administration last month intensified regulatory actions against labs offering pharmacogenetics services without premarket clearance or approval in an apparent attempt to prod more firms to submit their tests for regulatory review.

To read the full story....

...and receive Daily News bulletins.

Already have a 360Dx or GenomeWeb account?
Login Now.

Don't have a 360Dx or GenomeWeb account?
Register for Free.

Menu

FDA Stepping Up Actions Against PGx Testing, Forcing Some Labs to Stop Reporting Drug Information

To read the full story....

Breaking News

GenMark Diagnostics Preliminary Q2 Revenues Rise 118 Percent on SARS-CoV-2 Tests

Siemens Healthineers, EKF Diagnostics, Immucor, Horiba, Others Get FDA Clearances in June

Progenity Asks Court to Declare Non-Infringement of Natera Patents

FDA Issues New Guidance for SARS-CoV-2 Pooled Sample Testing

BD Rapid Coronavirus Antigen Test Gets FDA Emergency Use Authorization

Advanced Biological Laboratories Gets CE Mark for SARS-CoV-2 qPCR Assay

Featured White Papers

What's Popular?

FDA Letter Warns About False-Positive Results From Becton Dickinson SARS-CoV-2 Test

CDC Combined COVID-19/Influenza Test Gets FDA Emergency Use Authorization

InBios International Gets Emergency Use Authorization for Second Coronavirus Antibody Test

Sysmex Nabs Japan Approval for Automated Hematology Analyzer to Diagnose Malaria

Asuragen Receives CE Mark for Spinal Muscular Atrophy Assay

Sponsorships