Senators Question FDA’s Proposed Progressive Approval Pathway For Devices
US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.
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FDA’s Device Center Could Raid $2.8M From Staff Outreach, Training Kitty In 2021 To Fund Other CDRH Needs
While the Trump administration’s proposed fiscal year 2021 budget for the US FDA would give the agency’s device center a 5.3% increase for medtech product approvals and safety, the center’s lofty plans to become the world’s premier regulator of new AI-driven gadgets, next-gen diagnostics and other novel devices means it will have to tap about $2.8m dollars usually set aside for staff training and outreach to help meet its ambitious goals.
2020 Outlook: US Congress Will Address Surprise Billing, Ratify USMCA, Conduct More Medtech Safety Oversight
Congress was able to approve a permanent medical device tax repeal and pass a “LAB Act” bill favorable to the diagnostic industry in 2019. But what device-related legislation is ahead in 2020? Medtech Insight takes a look at some of the medtech bills and draft legislation likely to affect manufacturers pending in late 2019 that are likely to be reviewed – and perhaps approved – in 2020.
Device And Drug Accelerated Approval Pathways Important To Cancer Patients, US FDA Oncology Chief Pazdur Says
The Food and Drug Administration’s increased use of hastened approval pathways for innovative medical products, including new genomic device/drug combinations, has come in for criticism from some US Senators recently. But the patient group Friends of Cancer Research (FOCR) endorsed the approach at a 10 December meeting on Capitol Hill featuring FDA’s Oncology Center of Excellence director Richard Pazdur.