Dr. Richard Pazdur on the Breakthrough Designation Requirements

In Orphan Drug Congress by Tim Peplow

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 described these requirements at a special press briefing at the 2013 ASCO Annual Meeting.” (Source: OncLiveTV)