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.
By Ramsey Baghdadi
"How low can you go?" FDA Office of Oncology Drug Products director Richard Pazdur, MD, asked during the advisory committee...
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