Capitol Hill News In Brief
This article was originally published in The Gray Sheet
Senate passage sends trade promotion authority bill to President Obama for his signature; House “21st Century Cures” legislation gains 230 co-sponsors in the House; Senate Finance panel marks up disposable medical technologies bill.
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The targeted FDA Device Accountability Act mirrors select device sections of the House 21st Century Cures legislation seeking to strengthen the use of "least-burdensome" provisions, allow use of centralized IRBs for device trials and refining standards for diagnostic CLIA waivers.
Robert Califf, a former FDA commissioner turned Verily Life Sciences exec, is just one of the voice predicting a long-term impact on clinical trial processes from the COVID-19 outbreak.
A US National Academies meeting on digital health technology showcased the communication gap between regulators and tech developers when it comes to important concepts like “digital biomarkers.”