Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
Regulators of new products confront a trade-off between speeding a product to market and collecting additional product quality information.
Regulators of new products confront a trade-off between speeding a product to market and collecting additional product quality information.
Total US National Health Expenditures (NHE)—projected at $5.9 trillion for calendar year 2026, which represents 18.6% of GDP—are expected to rise to an unprecedented 20% of GDP by 2033.
The United States Food and Drug Administration’s (FDA’s) 510(k) pathway allows manufacturers to gain medical device approval by demonstrating substantial equivalence to a legally marketed device.
The U.S. health care system has long struggled to deliver high-quality care at a reasonable cost. Though there is plenty of blame to go around, fingers are often pointed at health insurers.
Background Antidepressants are among the most prescribed medications in the USA, yet challenges in access to mental health treatment persist. Objective To assess current and lifetime antidepressant a
IMPORTANCE Generative artificial intelligence (AI) has rapidly entered mainstream use in the US, but its association with mental health has not been characterized.
Large and persistent sociodemographic disparities in rates of mental health treatment in the United States have been reported, but whether these differences reflect institutional mistrust or limited s
The United States is in need of novel solutions to deliver mental health care, especially in the wake of inadequate community health financing following deinstitutionalization.
In the wake of the COVID-19 pandemic, inflation surged in the United States and across much of the globe.
Medicare home health care is often characterized as a postacute care benefit, yet community-entry users—those admitted without a preceding hospitalization—account for nearly half of all spending and e
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