Patient Advocacy Groups Pressure US Lawmakers To Pass VALID Act For Diagnostics Regulation
The Verifying Accurate, Leading-edge IVCT Development (VALID) Act is the “most comprehensive reform effort to date” for diagnostic tests, a group of 18 patient advocacy organizations has told Congress.
You may also be interested in...
The user fee package was among several health-related bills that the subcommittee took up on Wednesday.
A controversial Trump-era policy that blocked the US FDA from regulating laboratory-developed tests was binned by the Health and Human Services secretary on 15 November. As a result, the FDA will once again require emergency use authorizations or other clearances for new COVID-19 tests.
Abbott says it’s preparing for the possible passage of legislation that would, among other things, create a new regulatory framework for diagnostic tests. But the manufacturer is also asking for more specificity around the bill’s quality requirements.