New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Collaboration between several key pharmaceutical companies looks to remove barriers for cancer patients to improve treatment selection.
The FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
All of last week’s key cases announced by the DOJ involving the health care industry related to companies settling false claims-related allegations.
Recently published research shows that annual mammography rates for survivors aged 40 to 64 have been dropping since 2009.
Radeas LLC is also required to enter into a five-year corporate integrity agreement as part of the settlement.
Prosecution insists that Holmes and Balwani were “partners in everything, including their crimes.”
OIG report on Medicaid Fraud Control Unit enforcement activity in fiscal year FY 2021 shows recoveries are up, despite fewer cases.
In CE-IVD-related announcements made over last week, the majority involved the cancer testing market.
After peaking in the first quarter of 2021, with 42 SPACs raising a total of $11 billion, the blank-check company craze has fallen off significantly.
Last week, CMS announced that it was eliminating certain waivers and regulatory flexibility it provided when the COVID-19 pandemic began.