Senate Poised To Vote On Cures Bill; Headed To Likely Enactment This Term

Following House passage of a combined House/Senate 21st Century Cures package Nov. 30, the Senate will take up the bill on Dec. 5 or 6, said Senate HELP Committee Chair Lamar Alexander, R-Tenn., who shepherded a similar package of medical innovation bills through the committee earlier this year. While some Democrats remain vocal in opposing the bill based on worries that it will water-down FDA safety protections and funding concerns, the House vote showed lopsided support, and the Senate is expected to pass it and the president to sign.

Capitol House

A 21st Century Cures package including a US FDA breakthrough device pathway and other important medtech reforms is headed to the Senate floor for a vote as soon as Dec. 5 or 6following passage of the bill in the House on a bipartisan 392 to 26 vote Nov. 30.

Senate Health, Education, Labor and Pensions Committee Chair Lamar Alexander, R-Tenn., said he expects a "big vote" in the Senate...

More from Legislation

More from Policy & Regulation

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

From Imitation To Action: Johns Hopkins Robot Autonomously Performs Key Step In Gallbladder Surgery

 
• By 

Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

 

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.