Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical...more
Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more