Pew Responds To Draft Legislation Creating Regulatory Oversight Of Lab Developed Diagnostics

The time to create a flexible, risk-based regulatory system for all in vitro diagnostics is now, Pew tells US lawmakers, and offers suggestions to improve draft legislation that aims to do just that.

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While some proposed changes to how the US Food and Drug Administration regulates in vitro clinical tests will help to better protect patients, several provisions could undermine the agency’s efforts and need further clarification, according to The Pew Charitable Trusts.

In a letter to Senate Health, Education, Labor and Pensions (HELP) Committee chair Patty Murray, D-WA, and ranking member...

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