TAG:
in vitro clinical test
VALID Act vs. VITAL Act: Day of Reckoning for LDTs
TWO DISTINCTLY DIFFERENT BILLS HAVE SURFACED IN CONGRESS, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. One bill even creates a new acronym for the lab industry: IVCT for in vitro clinical tests….
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 XXIX, No. 10 – July 18, 2022
Theranos COO Ramesh “Sunny” Balwani has been found guilty of 12 counts of conspiracy and wire fraud, and The Dark Report examines his trial and compares it to that of CEO Elizabeth Holmes. Also, there are several important court rulings that will impact the way labs do business, as well as pending federal legislation to consider.
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