FDA’s Breakthrough Device Program Featured and more
Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.
Prospects for Omnibus FY 18 Appropriations by March 23: Complications Emerging? Yesterday, House Majority Leader McCarthy confirmed our impression that the House and Senate appropriations committees are nearly done with the nuts and bolts: FY 18 funding levels for every federal program. He would like to have the omnibus bill on the House floor next week, so that Congress will be well ahead of its March 23 deadline. However, it is unclear how they are going to handle policy riders to the appropriations bills; and its even murkier as to what non-appropriations items will go into the final legislation. Finally, yesterday, the White House informed Congressional leaders that it would veto an omnibus appropriations bill if it contained any monies for the NY-NJ Gateway tunnel project. So, we can only say: complications are emerging, but it is hard to tell how they will play out.
Highlight on Medical Technology: Alliance Meets with Dr. Shuren. This week, a team of 18 Alliance members and staff met with Dr. Jeff Shuren, director of FDA’s Center on Devices and Radiological Health (CDRH). Among other things, he highlighted the enormous surge in approval of novel devices (see chart) and discussed the key medical technology elements of the President’s FY 19 request for FDA. His remarks are covered in more detail in this week’s Analysis and Commentary.
FDA’s Breakthrough Device Program Featured. FDA Voice featured the agency’s Breakthrough Device Program and described how it works and what types of therapies might advance as a result. The example used is exciting: a brain implant being developed that would let some blind people see.
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