The Ethical and Legal Challenges in Unapproved Drug Access: A Talk with Patti Zettler
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Imagine being given a shot at a cure before it's even approved. That's the fascinating world of expanded access programs for unapproved investigational interventions that we're exploring today with our esteemed guest, Patti Zettler, law professor and chair of the International Society for Cell and Gene Therapies Expanded Access Working Group. We delve into the history of these programs, the FDA's role in their regulation, and the surge of interest they've seen in the last decade. Ever wondered why a patient would be willing to be a first mover on a yet-to-be-approved drug?…
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