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Senate Moves To Floor Phase For Innovation Bill; Postmarket Surveillance, LDTs Could Get Attention

This article was originally published in The Gray Sheet

Executive Summary

The Senate HELP Committee passed more measures for its planned medical innovation bill, including one affecting FDA's issuance of guidances versus formal rulemaking, and another in support of the administration's Precision Medicine initiative at an April 6 markup. Leadership also promised later floor debate on laboratory-developed test regulations and a device postmarket surveillance bill.

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