FDA Watch: Scientists Ask Agency to Rescind Approval for Opioid Management Test
Experts—including those in genetics and device regulation—say the AvertD assay did not predict risks of abuse ‘any better than chance’
Experts—including those in genetics and device regulation—say the AvertD assay did not predict risks of abuse ‘any better than chance’
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.