FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Articles and Reports
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Electronic Prior Authorization Bill Reintroduced in Congress
For clinical labs, the proposed law could bring more consistency to test ordering
Loper Bright Renews Interest in the VALID Act
The US Supreme Court decision that recently overturned the Chevron doctrine is influencing potential enactment of new legislation
September 2024 Labs in Court
Recent DOJ settlements continue to focus on issues involving medical necessity and marketer compensation
What Labs Need to Know About MolDX®
How the MolDX® program works, what it covers, and how it can support better test access, use, and reimbursement in the clinical lab
Special Report: The 2024 Lab Enforcement Landscape
Lab leaders should be wary of telemedicine arrangements, certain marketing firms, and unnecessary PGx and CGx testing
Electronic Device Use in the Laboratory: The Keys to Safety
Three main risks to consider when it comes to personal electronic devices, and how to safely incorporate their use in the laboratory
August 2024 Labs in Court
COVID-19-related schemes dominated recent enforcement efforts, which include a national healthcare fraud enforcement action
FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
Clinical Lab Education: The Role of Virtual Reality
How virtual reality technologies can support clinical laboratory education efforts and what leaders should know about implementation
Special Analysis: Addressing Key Concerns Around the FDA’s Final LDTs Rule
Experts answer key questions related to laboratory-developed test regulation during G2 Intelligence webinar.
