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
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FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
FDA Watch: Agency Issues New Guidance to Ease Approval of NGS Tests & IVD Devices
From - Laboratory Industry Report
April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing…
FDA Watch: 23andMe Continues to Spearhead Direct-to-Consumer Marketing of LDT Genetic Tests
From - Laboratory Industry Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…
FDA Watch: Personalized Medicine Approvals Continue to Flow
From - Laboratory Industry Report
After a slow start to the year, new product business picked up significantly in the past four weeks. Here's a rundown…
FDA Watch: Off-Label Marketing Rule Put Back on Ice & Extra Comment Time for CLIA Waiver Proposals
From - Laboratory Industry Report
For the second time in less than a year, the FDA indefinitely delayed a controversial rule expanding its authority to regulate off-label marketing…
FDA Watch: Greenlights for NGS Tumor Panels May Augur New Approach to LDT Approvals—Both Product & Pathway
From - Laboratory Industry Report
A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including…
LDTs: Top 10 New FDA Diagnostic Approvals of 2017
From - Laboratory Industry Report
The phrase "most exciting FDA laboratory developed test approvals of the year" is no longer an oxymoron. The agency remains glacial in tempo…
FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval
From - Laboratory Industry Report
For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests…
Kellison Award goes to FDA’s Dr. Alberto Gutierrez
From - Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…
FDA Watch: New Moves to Boost CLIA Transparency
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FDA Watch: Diagnostics Industry Is Losing a Longstanding “Frenemy”
From - Laboratory Industry Report
The diagnostics community is saying goodbye to a frenemy of 25 years. On Aug. 29, Alberto Gutierrez, director of the…