The Senate Full Committee Hearing titled ‘Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation’ included witness testimony from Francis Collins, Director, NIH and Scott Gottlieb, Commissioner, FDA.
NIH testimony includes the Agency’s focus on implementing the Cures Act and discussion of: big data, biomedicaxl workforce, system innovation to reduce administrative burden and increase efficiency, the NIH Innovation Fund, Precision Medicine, the BRAIN Initiative, the Cancer Moonshot, and the Regenerative Medicine Innovation Project.
FDA testimony discusses the Oncology Center for Excellence, minimal risk clinical investigations, digital health, breakthrough devices program, 510(k) modifications and exemptions, patient-focused drug development, drug development tools, Susceptibility Test Interpretive Criteria, and Real World Data and Real World Evidence.
Source: Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation, December 7, 2017. Watch the video or download the witness testimony here.