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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
Regulatory Roundup: New laws, regulations, cases, and enforcement actions affecting labs and the lab industry
This month’s roundup includes the continued court battle between BGI and Illumina, an FCA lawsuit, and the latest version of OSHA’s COVID-19 rule.
Ellume Faces Lawsuit for Not Refunding Costs of Recalled COVID-19 Tests
Company involved in recent Class 1 recalls of COVID-19 rapid tests now faces further fallout by not refunding customers for faulty tests.
CMS Launches Free Medicare Coverage of OTC COVID-19 Rapid Antigen Tests
Starting April 4, Medicare beneficiaries can get eight free tests per month for each month the public health emergency remains in effect.
Lawmakers Squabble as Country Runs Out of COVID-19 Response Money
The relief package agreed to on April 4 appears to have become a collateral victim of a politically incendiary issue regarding immigration.
It Was All Elizabeth Holmes’ Fault, Sunny’s Lawyers Claim
amesh “Sunny” Balwani’s legal team makes the case that Holmes is solely responsible for Theranos misdoings.
The Craze Is Over but Healthcare SPAC Deals Remain Alive and Well
A hot trend in capital raising for the healthcare and life sciences industries only two years ago, SPAC deals have petered out, but are far from dead.
Global Aspiration & Biopsy Needles Market to See Strong Growth
According to a recent report, this market will see almost seven percent annual growth over the next five years, reaching US $1.29 billion in 2026.
Analytic Systems Account for 5 of Top 10 Most Cited CLIA Deficiencies
CMS has published its list of top 10 most frequently cited Clinical Laboratory Improvement Amendments deficiencies for the previous year.
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.
Partnership to Create New Tool for Rapid SARS-CoV-2 Variant Detection
Thermo Fisher, Helix, and Rosalind collaborate on an NIH-supported project to develop a new genotyping method to ID virus variants faster.
