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”
Assay tech company shares that its Q1 2022 results were better than expected in spite of declines in COVID-19 product sales.
Recently introduced bill would require coverage of genomic cancer testing and follow-up screening for certain at-risk individuals.
With cyberattacks in the health care industry on the rise, it’s more important than ever for labs to protect patient information.
False and fraudulent claims, particularly those relating to COVID-19 and telemedicine, made up most of the key enforcement actions announced by the DOJ this past week
Study finds that three out of four blood tests produced different results depending on if they were used for White or Black people.
The DOJ recently charged defendants in nine different US districts for allegedly carrying out COVID-19 scams worth just over $149 million.
A recent AMP report offers recommendations to policymakers to prevent problems in future public health emergencies.
Malpractice premium costs are climbing at rates not seen since the turn of the century, according to a new AMA report.
With increasing media coverage about problems with genetic non-invasive prenatal screening, the agency warns of risks of false results.
While HHS hasn’t yet officially withdrawn SUNSET, recent indications are that it’s only a matter of time.