LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Congress Looks to Beef up Agency’s Power to Withdraw Unproven AA Drugs
The House Energy and Commerce Committee is considering a pair of rival bills, one Democratic and one Republican, to reform the AA process.
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Ellume Faces Class Action Lawsuit Over At-Home COVID-19 Test Kits
Back in October...
Labs in Court Weekly Roundup
In enforcement...
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Will We Be Better Prepared for the Next Pandemic?
The current...
New Technology Could Make Biopsies a Thing of the Past
NEW YORK, NY —...
Novel Method Effective for Screening Multiple Cancer Types
Finding cancer...
