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FDA Receives Thousands Of Opinions On Proposal To Regulate LDTs As Comment Period Comes To A Close

 
• By Brian Bossetta

As the US FDA works to finalize new regulation of lab-developed tests, it must consider more than two thousand comments that have poured into the agency since the proposed rule was published in October. The comment period closes Monday.

PROSvCONS
• Source: Shutterstock

The US Food and Drug Administration’s proposal to regulate laboratory-developed tests (LDTs) will either ensure patients receive accurate results they can depend on for making critical health decisions, or it will cripple diagnostics leading to significant patient harm.

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• By Sarah Karlin-Smith

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• By Elizabeth Orr

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