JD Supra

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA’s Proposed Phaseout Policy - Key Considerations & Open Questions

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would ...
JD Supra

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

A laboratory director of a nonwaived lab who holds a doctor of medicine (MD) or doctor of osteopathy (DO) degree must also be certified in anatomic pathology or clinical pathology, or both, by the ...

Evexia Diagnostics Expands At-Home Testing Capabilities with the Addition of Biobox™ by Access Labs

New at-home blood collection solution helps clinicians increase patient compliance, expand access to testing, and ...

Legacy Receives New York State CLEP Approval For Two Laboratory-Developed Tests: Semen Analysis And DNA Fragmentation

Legacy Receives New York State CLEP Approval For Two Laboratory-Developed Tests: Semen Analysis And DNA Fragmentation. Legacy clears New York's stringent pre-market review of laboratory-developed ...
Labroots

Facing Multi-Residue Complexity? Rethink Your Food Testing Workflow with the Thermo Scientific EFOX analytical solutions platform

Food testing laboratories are facing increasing pressure to deliver fast, reliable, and defensible results across complex matrices. Expanding pesticide panels, stricter regulatory expectations, and ...