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
Potential New Test Could Diagnose Lyme Disease Sooner
For scientists...
FDA and Industry Reach Agreement on MDUFA V Medical Device User Fees
For a while, it...
New Act Would Mean Wider Medicare Coverage of Genetic Cancer Screening
Legislation would require Medicare to cover genomic cancer testing and follow-up screening for those with a family history of cancer.
Theranos Story Gets the Miniseries Treatment on Hulu
Those who want...
Omicron-Affected Physicians Get a Break on 2021 MIPS Adjustments
...
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