1.53 CALGB 50303, REMoDL-B, & REMS, Orphan Drug Act, and Role of the FDA with Dr. Ameet Sarpatwari

Plenary Session

Vinay Prasad, MD MPH

Policy, Oncology, Science & Medicine, Medicine, Health

4.8 • 798 Ratings

🗓️ 11 April 2019

⏱️ 106 minutes

🔗️ Recording | iTunes | RSS

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Summary

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 Back us on Patreon! www.patreon.com/plenarysession

Transcript

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0:00.0	You're listening to Plenary Session.
0:09.5	This week on Plenary Session.
0:11.6	First, I'm sick.
0:13.5	I've been sick for the last few days.
0:16.3	But that doesn't stop me from being here in Plenary Session H H.Q. To record this episode. This episode, you're
0:22.7	in for a real treat. You've got a lot of things coming at you. First, I'm going to talk a bit about
0:27.1	two recent clinical trials in lymphoma. I'm going to try to put these in context in the
0:31.5	lymphoma landscape. Next, I have an interview with Dr. Amit Sarpatwari. and Dr. Sarpatwari is a lawyer and an epidemiologist
0:39.7	who works in the Harvard program on regulation therapeutics and law.
0:42.9	He is a scholar in regulatory matters, and there's no one more knowledgeable on issues of the Orphan Drug Act and RIMS,
0:50.1	which are two topics we're going to be talking about today.
0:52.4	In addition to the big topic, which is what is the role and what is the purpose of the U.S. Food and Drug Administration?
0:58.8	You won't want to miss this discussion.
1:00.7	So, stay tuned.
1:04.4	But first, a plug.
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