Nothing Random About It: The State of Cancer Drug Development at FDA
Executive Summary
FDA is getting tougher on cancer drug approvals. But stakeholders on all sides-industry, regulators, and patient groups-say that's probably a good thing. Under the leadership of Richard Pazdur, MD, the controversial director of FDA's newly formed Office of Oncology Drug Products, the agency is raising the bar for getting cancer drugs on the market.
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Hurry Up and Wait: The Slowdown in Accelerated Approvals
Accelerated approvals are decelerating. Sponsors argue the FDA is so caught up in the current emphasis on safety that they're raising the AA efficacy standards. The FDA contends that the companies who have been rejected aren't meeting the efficacy standards or performing the promised follow-up trials. Is the FDA changing the rules-or are companies themselves bending them? A look at several recent cases of AA therapies reveals that both are true.
FDA Faces Mounting Pressure on Shortcut Approval Pathway
The FDA has recently come under fire by big pharma and big biotech. The issue: FDA's interpretation of a section of the Federal Food, Drug, and Cosmetic Act-505(b)(2)-which allows companies to rely on data other than their own to attain drug approval.