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United States

Set Alert for Policy and Regulation United States

No-Device 'Right-To-Try' Bill Fails To Pass House Muster

"Right-to-try" legislation aimed at giving severely ill patients access to drug treatments not yet approved by US FDA failed to win support from the needed super-majority in a Tuesday night vote in the US House. Before the vote, the bill's scope was narrowed by removing medical device provisions, and making it applicable only to those facing death within a matter of months. A Senate version still in play retains the device language.

Legislation Policy Regulation

Latest From United States, Policy & Regulation

Medicare Finalizes NGS Test Coverage For Advanced Cancers, Drops Evidence-Collection Provision

The US Centers for Medicare and Medicaid Services March 16 said it will cover next-generation sequencing diagnostic laboratory tests for advanced cancers, broadening its final determination to cover use in relapsed, refractory and stage III cancers, while dropping "coverage with evidence development" conditions.

Reimbursement Market Access

FDA Works To Connect Cardiac Device Registries

US FDA is working with manufacturers, researchers and other stakeholders to assemble a comprehensive network of registries of cardiac device data. But cardiologists and device firms say the project faces multiple challenges.

Regulation Research & Development

Theranos' Holmes, Balwani Slammed By SEC For 'Massive Fraud'

In another blow from the US government, securities regulators have severely penalized Theranos and its cofounder, Elizabeth Holmes, for allegedly lying to investors to raise funds.

Enforcement Legal Issues

QUOTED. March 14, 2018. Jeff Shuren.

The head of US FDA's device center, Jeff Shuren, wants three manufacturers of duodenoscopes to fulfill their obligation to conduct post-market surveillance studies. Check out what he said about Olympus, Fujifilm and Pentax Medical here.

Quoted FDA

FDA Pathway Options Are Growing For Diagnostics, FDA's Gottlieb Tells Commercial Labs

While lab-developed test (LDTs) remain under a US FDA enforcement discretion policy, the agency is working on several fronts to offer appealing regulatory pathways for advanced diagnostic services, FDA Commissioner Scott Gottlieb told American Clinical Laboratory Association members.

Legislation Regulation

Contact-Lens Prescription Process Debated At US Trade Commission

The US Federal Trade Commission hosted a sometimes-contentious discussion on proposed changes to its Contact Lens Rule on March 8. One issue up for debate was which methods are appropriate when a contact-lens seller needs to confirm a prescription with a patient's eye doctor.

Policy Distribution
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