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Dr. Pazdur on Breakthrough Designation Requirements

Richard Pazdur, MD
Published: Friday, May 31, 2013

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, emphasizes the importance of adequate data supporting proposals to the FDA for breakthrough therapy designations.

Pazdur notes that several of the breakthrough therapy proposals that were denied by the FDA were due to inadequate preliminary evidence. This enhances the importance of communicating with the review division prior to submission, to ensure the requirements are met.

Pazdur described these requirements at a special press briefing at the 2013 ASCO Annual Meeting.

<<< View more from the 2013 ASCO Annual Meeting

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, emphasizes the importance of adequate data supporting proposals to the FDA for breakthrough therapy designations.

Pazdur notes that several of the breakthrough therapy proposals that were denied by the FDA were due to inadequate preliminary evidence. This enhances the importance of communicating with the review division prior to submission, to ensure the requirements are met.

Pazdur described these requirements at a special press briefing at the 2013 ASCO Annual Meeting.

<<< View more from the 2013 ASCO Annual Meeting


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