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

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.

A Senate committee approved a new round of medical innovation bills, including one to help FDA and the National Institutes of Health to attract better medical researchers and reviewers, and another supporting the Precision Medicine initiative, during an April 6 markup. And during the Senate Health, Education, Labor, and Pensions (HELP) Committee session, Chairman Lamar Alexander, R-Tenn., promised future floor debate "on the issue of lab-developed tests" and on postmarket surveillance of devices, even though the committee has not addressed those issues in its recent markups.

The chairman also said he was searching for an agreement with fellow senators on funding for a "one-time funding surge" for NIH to help support all the medical innovation priorities...

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