To improve evidence generation in studies designed to bring therapeutic agents to market, FDA is urging drug sponsors not to skip dose optimization at the outset of clinical development. The agency is also telling industry that it’s open to accepting trials that have pragmatic elements and are augmented by data generated in academia.
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...
