TAG:
Food and Drug Administration
What’s Next in 2023 for Clinical Laboratories?
AS YOU OPEN THIS ISSUE OF THE DARK REPORT, in New Orleans, about 900 senior lab administrators, executives, and pathologists will be gathered at the 28th annual Executive War College on …
OIG’s Issues New Opinion on Use of Gift Cards for Lab Specimens
CEO SUMMARY: This new Advisory Opinion from the Office of Inspector General (OIG) outlines a narrow situation in which it may be allowable for clinical laboratories to use gift cards to encourage pa…
IVD Firms Prepare for OTC, Home Test Market Expansion
CEO SUMMARY: With public interest in home testing growing, some IVD manufacturers are preparing to serve a fast-expanding market for over-the-counter and at-home tests. IVD firms are banking on the…
March 27, 2023, Intelligence: Late-Breaking Lab News
Clinical laboratory leaders watching at-home care evolve should note the new partnership between Best Buy and Atrium Health in Charlotte, North Carolina. As part of the deal, Best Buy Health, a division of the retailer, will assist patients in setting up the technology pieces of …
March 6, 2023, Intelligence: Late-Breaking Lab News
Since Congress did not include new regulations for laboratory-developed tests (LDTs) in a year-end spending budget, it appears the Food and Drug Administration (FDA) will take steps of its own to increase the agency’s oversight of LDTs. “We are moving forward with rulemaking,” said Eliza…
Eight Macro Trends for Clinical Labs in 2023
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
January 3, 2023, Intelligence: Late-Breaking Lab News
At the moment, it appears that the controversial Verifying Accurate Leading-edge IVCT Development (VALID) Act will have a hard time passing in Congress. The bill, which is intended to shift regulation of laboratory-developed tests (LDTs) to the federal Food and Drug Administration…
Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More
CEO SUMMARY: In this exclusive interview, Reynolds Salerno, PhD, the Director of the Division of Laboratory Systems at the CDC, offers insightful comments about the federal agency’s response to the SARS-CoV-2 pandemic, what went right during public health efforts, and lesson…
How Genomic Testing Labs Can Improve Their Relationships with Payers
CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially curtails speedy reimbursement of new and novel genomic test claims. A panel …
Important Court Rulings & Pending New Federal Law
IMPORTANT THINGS ARE HAPPENING WITH COURT DECISIONS AND PROPOSED FEDERAL LEGISLATION that will affect a substantial number of the nation’s clinical laboratories and anatomic pathology groups. In this issue of The Dark Report, you’ll be alerted to those developments we th…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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