ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
Six common forms of time theft to be on the lookout for, and how lab leaders can stop each one.
For labs and other healthcare providers, a bill now before the Senate could mean a less labor-intensive prior authorization process.
Though Congress didn’t pass VALID as part of the medical devices user fees bill, there’s still a good chance it will pass before year’s end.
Sentencing has been postponed for one month to explore possible government mishandling of key witness testimony.
What you need to know about the 308-page proposed rule and its potential impact on your lab, along with a basic strategy to implement it.
The problems began in January 2020 when hackers got access to an employee’s email account, compromising clients’ personal data.
The agency recently announced subtle but significant changes to its policies governing review of new lab tests for COVID-19.
A roundup of key mergers, acquisitions, and strategic asset purchases in the healthcare industry in September.
The Hilden, Germany-based company is extending its genetic testing profile beyond oncology to neurology biomarkers.
The agency recently stated that current testing capacity is adequate and established limits on its review of new EUA submissions.