Richard Pazdur, MD

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA&rsquo;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 Breakthrough Therapy proposals were denied by the FDA because of inadequate preliminary evidence. This enhances the importance of communicating with the review division prior to submission, to ensure the requirements are met.

Adequate preliminary evidence is crucial for a drug to receive a Breakthrough Therapy designation

Communication with the review division prior to submission can help to ensure requirements are met

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

Requirements for a Breakthrough Therapy Designation

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA&rsquo;s Center for Drug Evaluation and Research, describes the benefits of a Breakthrough Therapy Designation.

There have been several drugs in the past that would have benefited from the increased interaction between sponsors and the FDA from a Breakthrough Therapy Designation, Pazdur notes.

The concept behind a Breakthrough Therapy Designation is that the FDA will be involved with the sponsor on an ongoing basis to address clinical application, manufacturing issues, clinical pharmacology issues, and preclinical issues in a timely fashion.

There have been several drugs in the past that would have benefited from Breakthrough Therapy Designation

A Breakthrough Therapy Designation helps to address clinical application, manufacturing issues, clinical pharmacology issues, and preclinical issues

View all coverage from the 2013 ASCO Meeting

Richard Pazdur, MD, from the FDAâ€™s Center for Drug Evaluation and Research, describes the benefits of a Breakthrough Therapy Designation.

Richard Pazdur, MD | Authors

Articles

Requirements for a Breakthrough Therapy Designation

The Benefits of a Breakthrough Therapy Designation