Episode Description In this episode, Darshan Kulkarni sits down with former FDA Commissioner Robert Califf for a wide-ranging conversation on FDA authority, politics, guidance, and public trust. From the loss of Chevron deference to the role of FDA as a referee, Dr. Califf explains how regulation really works and why wealth inequality has become the most serious health issue in the United States. Episode Summary What does it really take to run the FDA, and how political should the agency be? ...
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Episode Description In this episode, Darshan Kulkarni sits down with former FDA Commissioner Robert Califf for a wide-ranging conversation on FDA authority, politics, guidance, and public trust. From the loss of Chevron deference to the role of FDA as a referee, Dr. Califf explains how regulation really works and why wealth inequality has become the most serious health issue in the United States. Episode Summary What does it really take to run the FDA, and how political should the agency be? ...
Are Pharma Chatbots Putting You at Regulatory Risk?
DarshanTalks Podcast
5 minutes
2 months ago
Are Pharma Chatbots Putting You at Regulatory Risk?
Pharmaceutical chatbots are increasingly used to answer patient drug questions, but they carry significant regulatory and compliance risks. While the FDA has issued guidance on AI in drug development and medical devices, it does not yet provide a framework for patient-facing drug Q&A. That means chatbots that discuss side effects, dosing, or interactions exist in a gray zone, and any missteps could trigger FDA enforcement. The FTC enforces truth in advertising and consumer protection. Mis...
DarshanTalks Podcast
Episode Description In this episode, Darshan Kulkarni sits down with former FDA Commissioner Robert Califf for a wide-ranging conversation on FDA authority, politics, guidance, and public trust. From the loss of Chevron deference to the role of FDA as a referee, Dr. Califf explains how regulation really works and why wealth inequality has become the most serious health issue in the United States. Episode Summary What does it really take to run the FDA, and how political should the agency be? ...
