FDA Watch: EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
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Articles and Reports
Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
FDA Watch: Key Lab Test Clearances of 2023
G2’s list of major FDA approvals includes cancer and liquid biopsy, COVID-19, STI, and neurologic tests.
The Future of Laboratory-Developed Tests
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
Congress Retables VALID and VITAL Legislation to Regulate LDTs
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FDA Pulls the Plug on EUA Review of COVID-19 LDTs
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Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs
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FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests
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Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
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