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- Aligning Stakeholder Partnerships in Latin America
- Policies to Promote Development of AI-Based Medical Devices in Japan
- Conversation with Australian Pharmaceutical medical and scientific Professionals Association (APPA) Past President David Grolman
- Patient Entrepreneurs: The New Driving Force for Developing Health Solutions
- Perspectives on FDA’s Accelerated Approval Program
Perspectives on FDA’s Accelerated Approval Program
While it is clear that FDA and drug sponsors must work together to proactively plan and diligently implement clinical trials for the collection of data sufficient to “convert” accelerated approval into traditional approval, equally important is ensuring that while clinical trials are pending, patients who receive AAP-approved drugs in the clinical setting fully understand the program, its limitations, and the tradeoffs they are making.
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