The breakthrough designation, intended for cancer drugs and treatments of other life-threatening conditions, has transformed communication between the FDA and drugmakers, said Dr. Richard Pazdur, director of the FDA Office of Oncology and Hematology Products. Some applications have been rejected partly because drugmakers made a decision too soon based on just a small number of patients, Pazdur said. The review process helped speed up many approvals, but it doesn't mean that the agency's standards have fallen, Matthew Herper writes in this article.

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