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 recently developed bioelectronic tool could make health monitoring less invasive for babies in newborn intensive care units.
The algorithm, designed to help diagnose pulmonary hypertension earlier, aims to ensure patients get treatment sooner.
The FDA will almost certainly keep EUA tests on the market after the PHE expires.
Settlements for False Claims Act allegations the theme in recent enforcement actions involving the healthcare industry.
Recent study shows that different diabetes screening guidelines are required to produce equal benefits for certain racial groups.
Recent health care industry-related cases involved a variety of fraud types, including kickbacks and fake vaccine card distribution.
Meeting for the second Global COVID-19 Summit, leaders from around the world made additional financial commitments to fighting the disease
The relaxed regulatory environment labs have provided during the COVID-19 pandemic is set to come to and end soon.
New report says between 5.3 and 14.2 million people will lose their Medicaid coverage when the COVID-19 public health emergency ends.
Guidance from the American College of Medical Genetics and Genomics shares the importance of a genetic evaluation for hearing loss.