If President Donald Trump appoints, and the Senate approves, a new conservative justice for the Supreme Court to replace Ruth Bader Ginsburg, Affordable Care Act coverage could disappear. Two legal experts weigh in on this and other legal issues that could touch the medical device industry.
The passing of liberal US Supreme Court Justice Ruth Bader Ginsburg on 18 September jeopardizes Affordable Care Act coverage of medtech used to treat existing conditions including heart disease, cancer and diabetes, if the court rules to strike the entire ACA down in an upcoming case on its docket.
Washington, DC, lawyer Kyle Sampson says Ginsburg “was a true, liberal icon,” and appointment of a new conservative female justice...
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
