Chevron Doctrine’s Dismissal Has Yet to Upend Regulatory Environment
However, clinical laboratories may have more say in future laws and guidance thanks to 2024 decision
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FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
FDA Watch: BD Receives FDA Approval for Veritor, a Pandemic Staple
The assay was widely used during the early months of COVID-19 and was a significant source of revenue growth for a time
FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests
From - Laboratory Industry Report
Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new…
FDA Watch: Why the New NGS Guidance May Be a Paper Tiger
From - Laboratory Industry Report
Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing…
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…
