FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
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Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
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…
FDA Watch: Two More Zika Tests Get Emergency Use Authorization
From - Laboratory Industry Report
Zika made the FDA headlines this month, with two more tests receiving emergency use authorization…
FDA Watch: Another First as Agency Approves NGS Oncology Companion Dx for Multiple Therapies
From - Laboratory Industry Report
The FDA made a stir in May by approving a cancer drug (Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor from Merck) administered on the basis of a…