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Congress
FDA Issues Memo to Reclassify Many High Risk IVD Assays
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
2024: Year of Decision for FDA Regulation of LDTs
FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…
Year’s Top 10 Lab Stories Contain Surprises & Twists
CEO SUMMARY: With the SARS-CoV-2 pandemic now in the rearview mirror of the nation’s clinical labs and pathology groups, the important news stories of 2023 were mostly about developments where the consequences will influence laboratory operations in coming years. Artificial intelligence…
Congress Averts PAMA Cuts to Lab Test Rates for 2023
CONGRESS ENACTED LEGISLATION LAST MONTH that suspends implementation of the next round of price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) that was scheduled to take effect on Jan. 1. This is a welcome development for the medical laboratory industry….
2022’s Top 10 Lab Stories Confirm Challenging Times
CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …
Congress Votes: No PAMA Price Cuts for 2022
IT’S WELCOME NEWS THAT CONGRESS VOTED EARLIER THIS MONTH to defer the PAMA price cuts to the Clinical Laboratory Fee Schedule (CLFS) that were scheduled to take place in 2022. This is a positive development for the finances of the nation’s clinical labs, particularly the smaller, independent labs t…
Congress May Soon Act on LDT, IVCT Regulation
CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…
Congress May Soon Act on IVCT, LDT Regulation
This is an excerpt of a 2,017-word article in the November 29, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …
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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