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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Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move
Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
Compliance Corner: Must Employee Notify Lab of DUI?
QUESTION If one...
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New Laws: Proposed Kickback Changes Would Provide Needed Relief But Also Largely Exclude Labs
In what could be the most significant story in health care fraud and abuse compliance of the past several years, the CMS and OIG proposed new rules (the Proposal) to adapt 20th century kickback laws to 21st century market conditions,
New Product Development: FDA Issues Final Guidance on IVD Oncology Trials
On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether
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Quest Shells Out $195K to Settle Massive HIV Data Breach Class Action
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Global News: EU Delays Launch of Eudamed Database
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PAMA Report: ACLA Tries for Decisive Blow in Federal Court Case
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