FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
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.