The FDA Oncologic Drugs Advisory Committee July 25 voted unanimously to set more rigorous standards for new trials for approval of perioperative indications of cancer drugs.
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...
