LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
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FDA Watch: How Could the Change in US Government Affect IVDs and Labs?
Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing
FDA Watch: FDA Moves Slowly on AI-Driven Lab Devices
The agency has approved fewer than 10 tests in the past three years, but a new pipeline of AI-powered products is expected to emerge soon
FDA Watch: New Guidance on Charging for Investigational Drugs
On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.
FDA Re-Opens Pre-Submission Requests for Non-COVID-19 IVD Tests
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
FDA to Continue Remote Regulatory Assessments after Pandemic Ends
Meant to be temporary, remote regulatory assessments proved so successful that the agency will not only continue, but expand their use.
Bill to Regulate LDTs Advances, but Is No Slam Dunk for Final Passage
Now that the finishing touches have been put on LDT-related legislation, what is the likelihood that it will pass?
New VALID Act Would Establish Risk-Based System for LDTs Regulation
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.
FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
EUA COVID-19 Tests to Remain on US Market After PHE Expires
The FDA has plans to ensure COVID-19 test makers won’t be left high and dry when the public health emergency ends.
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.
Harmonizing Device CGMP Requirements with International Standards
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A Big Step for CRISPR-Based SARS-CoV-2 Test
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