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Once A Cheerleader For Latest VALID Act For Diagnostics, Pew Now Has Some Reservations

 
• By Shawn M. Schmitt

Public policy group The Pew Charitable Trusts is concerned that the latest iteration of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act prioritizes a faster time to market over patient safety. The group had previously signed onto a letter praising the proposed legislation, which aims to build a new regulatory framework for diagnostics in the US.

Smiley face and sad face on scale.

Two months after signing onto a letter praising proposed legislation that would build a new regulatory framework for diagnostics, public policy group The Pew Charitable Trusts now says it’s worried that the bill as it stands would jeopardize patient safety in its pursuit of a faster time to market for test developers.

The Verifying Accurate, Leading-edge IVCT Development (VALID) Act establishes a novel regulatory category called in vitro clinical tests (IVCTs), to include current laboratory developed test (LDT) services and IVDs...

The 245-page VALID Act also aims to modernize the review process for diagnostics, as well as clarify the roles played by the US Food and Drug Administration and the Centers...

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