1.53 CALGB 50303, REMoDL-B, & REMS, Orphan Drug Act, and Role of the FDA with Dr. Ameet Sarpatwari
Apr 11, 2019•1 hr 46 min
Episode description
We begin this episode with a discussion of two recent clinical trials in lymphoma: CALGB 50303 and REMoDL-B, respectively published in the Journal of Clinical Oncology and The Lancet Oncology. We include a primer on the history of lymphoma and the development of R-CHOP. We follow that with an in-depth interview with Dr. Ameet Sarpatwari of the Harvard Medical School on Risk Evaluation and Mitigation Strategies (REMS), the Orphan Drug Act, and, broadly, the purpose of the US FDA.
CALGB 50303: doi.org/10.1200/JCO.18.01994
REMoDL-B: doi.org/10.1016/S1470-2045(18)30935-5
Dr. Sarpatwari's online course: https://www.edx.org/course/the-fda-and-prescription-drugs-current-controversies-in-context
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