FDA official: Breakthrough cancer meds should be transformative

06/4/2013 | Wall Street Journal, The

Cancer treatments that receive the FDA's breakthrough designation should be transformative, said Dr. Richard Pazdur, head of the agency's office of hematology and oncology products. Breakthrough status involves continuous dialogue between FDA staff and the drug's developer, allowing regulators to suggest changes that can lead to more tailored, faster trials, Pazdur said at the American Society of Clinical Oncology's annual meeting.

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