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Latest From Sue Darcey
The US Senate Appropriations Committee passed FDA funding levels for 2020 on 19 September that would support medical device cybersecurity and medtech manufacturing, but a continuing resolution measure is waiting in the wings to provide the full Senate more time to consider the measure before the new fiscal year starts on 1 October.
The US agency has introduced a new action plan geared toward handling an expected incoming storm of real world evidence (RWE) data that companies will be submitting to support future device and drug approvals.
While the US Senate Appropriations subpanel handling FDA funding plans to mark up a 2020 funding bill for the agency on 17 September, disagreement between the Senate and House on agency spending caps could delay the final funding accord between the two chambers, forcing the FDA to run on continuing resolution dollars in early October.
Providers and suppliers to Medicare, Medicaid and the Children’s Health Insurance Program (CHIP) are required to disclose any affiliations they've had with individuals who've committed fraud under federal health-care programs under a final rule released on 10 September.
Obstetricians and maternal health research experts at a 10 September US House hearing on ways to lower maternal mortality rates supported passage of H.R. 2602, which would promote greater use of telemedicine as a means for expectant and new mothers to gain mental-health counseling and health-care advice from providers, among other provisions.
Rep. Shimkus, Author Of 'Cures' Device Provisions, Joins Exodus Of Republicans Retiring In 2020 From US House
Illinois Rep. John Shimkus, a well-known pro-medtech industry bill sponsor, announced on 30 August his plans for a January 2020 retirement. He joins at least 15 Republican House members who recently said they are also ending their Capitol Hill careers, leaving six vacancies on the US House Energy and Commerce and Ways and Means panels prior to the 2020 elections.