LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
A new analysis by ECRI shows that, while patients are also common targets, providers had to face racist behavior or comments most often.
Learn more about how to tackle the key staffing challenges facing diagnostics laboratories today and tomorrow.
Learn more about practical ways you can handle today’s lab staffing challenges, and how to prepare for those of the future.
Abbott’s Alinity m MPXV assay for detecting DNA from the monkeypox virus received FDA EUA on Oct. 7.
Learn more about how Congress could change PAMA, why it matters to your lab, and how you can prepare.
The pandemic came with great pain and suffering for many, but it also allowed telehealth and other technologies to flourish.
Learn more about how leveraging data automation to get clean patient data at the front end can be a game changer for labs.
The CDRH Total Product Life Cycle Advisory Program Pilot aims to improve the FDA authorization process for medical devices.
The new deal provides the FDA a minimum of $1.78 billion in user fees from 2023 to 2027.
In this week’s enforcement roundup, Radeas reaches a settlement with the State of North Carolina after alleged improper billing.