The Benefits of a Breakthrough Therapy Designation

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

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’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.

Clinical Pearls

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

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