ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
G2’s list of major FDA approvals includes cancer and liquid biopsy, COVID-19, STI, and neurologic tests.
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.