Drastic policy change will stifle diagnostic innovation, impose billions of unnecessary dollars in healthcare mandates, and threaten patient access to essential medical procedures
Public comments to the FDA’s draft guidances proposing enforcement policies for LDTs with and without a 564 Declared Emergency reveal a mix of support and opposition
In a statement, ADLM president Octavia Peck Palmer strongly supports Rep. Cassidy’s letter to the FDA asking how the agency plans to change its current practices under the recent Supreme Court ruling
The RNA-based test enables single-visit testing for HCV in about an hour, streamlining access to treatment
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