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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Balwani Loses Bid to Bar Incriminating Evidence from Fraud Trial
Even before the trial began, things got off to a rocky start for the ex-Theranos CEO, who faces charges of fraud and wire fraud.
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.
ONC Seeking Public Input on Electronic Prior Authorization Standards
The ONC requested input on certification standards for the development and implementation of electronic prior authorization IT products.
Website Ad Doesn’t Bar Qui Tam Suit for Rewards Program Fraud
A new case from the US Court of Appeals for the Ninth Circuit tests how far the public disclosure bar goes.
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