Pragmatica-Lung, the first study born from a broader effort by NCI, FDA, industry, academia, and advocacy groups to modernize the clinical trial process, has begun enrolling patients.
By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it. To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...
